Published Studies and Abstracts

HMR has supported numerous research studies, many of which have resulted in papers published in scientific journals or abstracts presented at professional conferences. Following is a partial listing of studies and abstracts, including a brief summary of the main findings.

Weight Management Results

Furlow EA, Anderson JW. A systematic review of targeted outcomes associated with medically supervised commercial weight loss program. J Am Diet Assoc 2009;109:1417-1421.
Weights, behavioral data and side effects for 173 consecutive patients from the HMR Program were assessed. Healthy Solutions patients (using meal replacements and vegetables and fruit) who completed at least 12 weeks of weight loss lost an average of 37.5 lbs in 18 weeks and Medically Supervised patients lost an average of 43.4
lbs in 19 weeks.

Befort CA, Stewart EE, Smith BK, Gibson CA, Sullivan DK, Donnelly JE. Weight maintenance, behaviors and barriers among previous participants of a university-based weight control program. Int J Obes 2008;32:519-526.
76.5% of previous program participants (n=179) had successfully maintained a weight loss of > 5% below baseline for 14 months. Successful maintainers reported that they ate five or more fruits and vegetables per day, continued to use meal replacements, and exercised more, kept exercise records and planned for exercise significantly more often than unsuccessful maintainers.

Anderson JW, Conley SB, Nicholas AS. One-hundred pound weight losses with intensive behavioral program: report of 118 patients with risk factor changes and long-term follow-up. Am J Clin Nutr 2007;86:301-307.
One hundred eighteen patients weighed an average of 352 lbs on entering the HMR Program and lost an average of 134 lbs. in 44 weeks. Medication doses were reduced in all patients who entered the program on medications. Medications were discontinued in 66% of all patients, including 100% of patients with dyslipidemia, 67% with hypertension, and 73% with diabetes.

Anderson JW, Grant L, Gotthelf L, Stifler LTP. Weight loss and long-term follow-up of severely obese individuals treated with an intense behavioral program. Int J Obes 2007;31:488-493.
Results for 1100 people with BMIs > 40 kg/m2 who completed the 12-week program showed an average weight loss of 77 lbs. Twenty-five percent (25%) of this group lost 100 lbs or more – for an average weight loss of 137.4 lbs. These patients were still maintaining a significant portion of that weight loss 1 ½ to 2 years later.

LeCheminant JD, Kirk EP, Hall MA, Bailey BW, Jacobsen DJ, Stewart EE, Donnelly JE. Impact of different levels of weight loss on blood pressure in overweight and obese women. Dis Manag 2007;10:83-90.
After losing weight on an HMR very-low-calorie diet, 159 women were grouped according to the proportion of weight loss after 6 months. Differences in systolic and diastolic blood pressure were found in dose response fashion for weight loss. These data indicate that increasing weight loss beyond 10% of initial body weight may provide added improvements in blood pressure compared to less than 10% weight loss.

Anderson JW, Reynolds R, Rinsky J, Bush H, Washnock C. Weight loss with a behavioral program using meal replacements, fruit and vegetables: a 24-week randomized, controlled trial. Obes 2009;17suppl 2:S265.
Patients randomized to the HMR Healthy Solutions diet (3 shakes, 2 entrees, 5 fruits and vegetables) who completed 12 weeks, lost an average of 33.4 lbs (15.4% of initial weight) compared to those receiving conventional dietetic counseling (these patients lost an average of 1.3 lbs or .6% of initial).

Anderson JW, Owen S, Fajardo B, Berkson J, File A, Cramer S, Gotthelf L. Assessment of weight maintenance at five years after behavioral weight loss intervention. Obes 2009;17 suppl 2:S87.
Weight change over 5 years was assessed in participants who lost an average of 65.6 lbs. When analyzed by quartiles, it was found that 52% of patients were keeping o > 5% of initial weight at 5 years, 31% were keeping off > 10%, 24% > 15% and 15% > 20% of initial weight. One-quarter of the patients were highly successful in maintaining an average of 97% of the weight loss at 5 years.

Anderson JW, Jhaveri M. Sequential changes in serum aminotransferases for obese individuals with weight losses of 25 to 170 lbs in behavioral low-energy diet program. Obes 2009;17 suppl 2:S262.
This study documented sequential changes of serum aminotransferases for persons with mild, moderate, or severe obesity who lost substantial weight in the HMR Program. It was found that this obese population had a very high frequency of ALT elevations with weight loss but these elevations were transient and values usually returned to below baseline after substantial weight loss.

Grant L, Gotthelf L. Obese patients who decrease BMI to overweight range have significant changes in lifestyle and medical risk factors. Obes 2009;17 suppl 2:S279.
Obese patients who lost an average of 52 lbs and moved from the obese to overweight BMI category experienced substantial health changes. 35.7% who were initially on cholesterol, blood pressure, or diabetes medications eliminated these medications (data on dosage decreases were not available). 55% of those on diabetes medications discontinued those medications.

Gotthelf L, Grant L. Improvement in medical risk factors for 1,000 patients in ongoing treatment program. Obes 2009;17 suppl 2:S279.
Health risk appraisal data from 1,000 consecutive participants in 26 HMR programs found the average weight loss to be 41 lbs (16.7% of initial weight) over an average of 2.8 years. Overall 72.6% of patients were keeping off an average of 21.4% of initial weight. There were also significant decreases in total cholesterol/HDL (12.1%), triglycerides (24.2%), fasting blood glucose (7.7%), and systolic (6 mmHg) and diastolic (4 mmHg) blood
pressure.

Anderson J, Furlow E. Weight loss with intensive behavioral treatment and low-energy diets: response of 195 consecutive patients. Obes 2008;16 suppl 1:S148.
The average weight loss for 195 patients (intent-to-treat) was 32.5 lbs or 13% of initial body weight. Completers (n=145) lost an average of 40.5 lbs or 16.1% in 17.5 weeks. Intensive behavioral therapy using meal replacements as the core of a low-energy diet is very effective.

Anderson J. Liver-function test changes with substantial weight loss. Obes 2008;16 suppl 1:S203.
Liver function tests (LFTs) were assessed every 2-4 weeks in two groups of patients. With weight losses of 3-6 lbs per week, patients had transient increases in LFTs with subsequent return to normal by 16 weeks in 98%. Most of the patients had benign steatosis that benefited from rapid and significant weight loss.

Grant L, Gotthelf L. 100 lb weight loss in intensive behavioral program results in reduction in medical risk factors. Obes 2008;16 suppl 1:S158.
Data from 139 consecutive patients from 28 medical facilities who lost > 100 lbs were analyzed using an initial and a follow-up health risk appraisal (HRA). The average weight change was 133 lbs or 38.7% of initial body weight over an average of 2.4 years. At follow-up, a large percent of patients were off their medications: 65.5% off oral diabetes medications, 83.3% off insulin, 43.7% off cholesterol medications, and 50.0% off blood pressure medications.

Gotthelf L, Grant L. Using a greater number of meal replacement entrees helps prevent weight regain in maintenance. Obes 2008;16 suppl 1:S158.
Data were analyzed from 142 consecutive maintenance patients who had participated in Healthy Solutions for weight loss. The average weight loss was 31 lbs in an average of 17 weeks. Those who used > 12 entrees per week lost an average of 7.8 lbs in maintenance while those who used < 12 entrees per week gained an average of .08 lbs.

Gotthelf L, Grant L. 114,000 people in weight loss program over 15 years show increase in entering weight and medications. Obes 2008;16 suppl 1:S158.
All patients (n=114,692) who had completed a health risk appraisal when they entered the HMR Program from 1991 to present were included and analyzed by 4 time frames. For each time frame, the percent of patients who were on cholesterol, blood pressure, oral diabetes medications and insulin increased. Although program outcomes have improved in the past 15 years, patients are entering treatment programs at higher weights and
with greater medical co-morbidities.

Grant L, Gotthelf L. Impact of weight loss on patients with high TC/HDL ratios. Obes 2008;16 suppl 1:S308.
Patients (n=331) who entered the HMR Program with TC/HDL > 5.0 and were not on medications were included in the analysis. From initial to follow-up health risk appraisal, patients lost an average of 49 lbs (18.5%) and made substantial lifestyle changes. TC/HDL ratio decreased an average of 25.9% and triglycerides decreased 36.7%. The average number of elevated risk factors decreased from 8 to 3.

Grant L, Gotthelf L. Three behaviors which prevented weight regain in maintenance. Obes 2008;16 suppl 1:S157.
Data were analyzed from 165 consecutive patients who completed 6 months of maintenance. On average, patients were doing an 2695 kcals of physical activity per week, 48.5 servings of vegetables and fruits per week, and 29.6 meal replacements per week and were experiencing virtually no weight regain at 6 months (-0.14 lbs). When each patient’s data was analyzed for each week in maintenance, however, it was found that most
patients seem to require different levels of these behaviors at different times in order to manage their weight.

Weithman CK, Gotthelf L, Grant L. Patients completing 12 weeks in structured maintenance program continue lifestyle changes and prevent weight regain. J Am Diet Assoc 2008;108 suppl3:A39.
Data from 124 consecutive patients found that patients continued to practice lifestyle behaviors over the 12 weeks of maintenance (average of 2319 kcals of physical activity, 45 servings of vegetables and fruits, and 29.6 meal replacements per week). During this time, patients lost an additional 4.5 lbs, on average, for a total weight loss of 33.6 lbs.

Anderson J, Owen S, Fajardo B, Berkson J, File A, Cramer S, Gotthelf L. Four-year efficacy and safety of sibutramine for weight maintenance: a multicenter, double-blind, randomized, placebo-controlled study. Obes 2008;16 suppl 1:S64.
Severely obese patients who lost 26.3% of initial body weight (66.2 lbs) in nonpharmacological weight loss programs maintained weight losses of 37.8% (25.1 lbs) over follow-up of 6 years. Sibutramine significantly enhanced weight maintenance for the first 24 months but weight changes did not differ significantly between
placebo and medication after that time.

LeCheminant JD, Gibson CA, Sullivan DK, Hall S, Washburn R, Vernon MC et al. Comparison of a low carbohydrate and low fat diet for weight maintenance in overweight or obese adults enrolled in a clinical weight management program. Nutr J 2007;6:36.
After losing 18-19% of initial body weight on an HMR very-low-calorie diet, a low fat and a low carbohydrate diet group, combined with a clinical weight management program, were similar and effective in preventing weight regain over 6 months.

Grant L, Gotthelf L. Patients with hypertension who lose substantial amounts of weight can positively impact risk factors and need for medications. Obes 2007;15 suppl:A98.
Patients with high blood pressure but not on medications at the time of program entry were followed in maintenance. Patients who lost substantial amounts of weight (average of 54 lbs) and made lifestyle changes (along with decreases in medical risk factors) were able, on average, to avoid the need for hypertensive medications.

Gotthelf L, Grant L. Weight loss in five treatment options in a structured behavioral program. Obes 2006;14 suppl:A101.
The weight loss outcomes of five treatment options in the HMR Program were evaluated. Medically supervised patients (n = 734) lost an average of 60.9 lbs. or 22.6% of initial body weight in an average of 29 weeks. Healthy Solutions patients (n = 309) lost an average of 41.4 lbs. or 18.5% of initial body weight in an average of 27 weeks.

Gotthelf L, Grant L. High compliance with lifestyle behaviors for weight management is possible. Obes 2006;14 suppl:A100.
Data from 1305 weight loss and 870 maintenance patients were evaluated for compliance in the HMR Program for Weight Management. Having high standards for program compliance and using behavioral strategies to meet these goals leads to high compliance in lifestyle changes (e.g., physical activity) and program variables (e.g., attendance).

Grant L, Gotthelf L. Prehypertensive patients substantially improve risk factors in a weight management program. Obes 2006;14 suppl:A101.
Initial risk factor data from patients who were prehypertensive when they entered the HMR Program for Weight Management were compared with data an average of 2.7 years later. Patients had significant decreases in all measured medical risk factors. 94.3% of patients remained free of blood pressure medications and 84.6% discontinued diabetes medications.

Grant L, Gotthelf L. Weight maintenance with five clinic-based and phone-based treatment options. Obes 2006;14 suppl:A101.
603 medically supervised patients were maintaining an average of 71.1% of their weight loss (average weight loss was 62.8 lbs) over a total of 63.9 weeks of treatment. Healthy Solutions patients (n = 259) were maintaining an average of 66% of their weight loss (average weight loss was 41.6 lbs) over a total of 65.4 treatment weeks.

May S, Grant L, Gotthelf L. Losing greater amounts of weight leads to greater changes in medical risk factors. Obes 2006;14 suppl:A103.
Data from 2564 patients in 65 HMR clinics were analyzed by percent of initial body weight kept off. All measured medical risk factors decreased significantly more in those losing the most weight as compared to all other groups. Patients reporting the greatest changes in lifestyle behaviors lost more weight, indicating a dose response relationship.

Anderson JW, Furlow EA. Specific and differential responses of serum lipoproteins to weight loss of > 100 pounds. Obes 2006;14 suppl:A166.
Substantial weight loss has selective eects on lipoproteins: LDL cholesterol gradually decreased and then began to increase and triglycerides decreased progressively. HDL cholesterol decreased rapidly in 4-8 weeks, returned to baseline at completion of weight loss and then significantly increased at one year. Overall, weight loss was
found to improve all lipoprotein risk factors.

LeCheminant JD, Jacobsen DJ, Hall MA, Donnelly JE. A comparison of meal replacements and medication in weight maintenance after weight loss. J Am Coll Nutr 2005;24:347-353.
After an average weight loss of 49.9 lbs. with a very-low-calorie diet, using 2 HMR meal replacement entrée a day was effective in maintaining weight loss within 6 lbs over one year.

Grant L, Gotthelf L. Long-term follow-up of 1,000 maintenance patients shows substantial lifestyle and medical changes. Obes Res 2005;13 suppl:A203.
1,000 maintenance patients were maintaining an average weight loss of 44 pounds (18% of initial body weight) after an average of 2 ½ years. Participants had made substantial lifestyle changes and had highly significant decreases in all measured medical parameters, such as fasting blood glucose, blood pressure, total cholesterol/HDL ratio, and triglycerides.

Gotthelf L, Anderson JW, Grant L. Intensive behavioral program is a successful treatment option for severely obese patients with BMI > 40. Obes Res 2005;13 suppl:A203.
1,136 participants who completed at least 12 weeks in weight loss treatment lost an average of 78.1 lbs. over an average of 37.2 weeks. Nearly ¼ of these participants lost > 100 lbs. and those who entered maintenance were keeping off an average of 69% of this weight loss (94.5 lbs.) over an average of 2.7 years.

Grant L, Anderson JW, Gotthelf L. Response of men and women with BMI > 40 to intensive treatment program for weight management. Obes Res 2005;13 suppl:A144.
This study analyzed data from 1,136 men and women who entered the HMR Program with a BMI > 40 kg/m2 and completed at least 12 weeks of weight loss. Men in this sample tended to sustain more of their weight loss. However, men and women who had lost > 100 lbs. were both maintaining an average weight loss of 27% of initial body weight after 2 ½ to nearly 3 years.

Gotthelf L, Anderson J, O’Brien B. Weight loss in overweight or obese individuals with different structured interventions in an intense behavioral program. Obes Res 2004;12 suppl:A40.
In a recent sample of weight loss participants, medically supervised HMR patients lost an average of 56.8 pounds in an average of 24 weeks and HMR Healthy Solutions™ patients lost an average of 36.7 pounds in an average of 20 weeks. Average reported physical activity was over 2,000 calories per week for all groups.

Anderson JW. Improved long-term maintenance of weight loss with ongoing involvement in weight management program. Obes Res 2004;12 suppl:A41.
Fifty-four participants who lost > 100 lbs. (average weight loss was 140 lbs.) were maintaining 70% of this weight loss (average of 100 lbs.) at an average of over three years.

Nicholas AS, Anderson JW. Reductions in blood pressure and medication costs with 100 pound weight loss. Obes Res 2004;12 suppl:A38.
For participants who lost > 100 lbs., systolic and diastolic blood pressure decreased 12-15%, antihypertensive medications decreased 72%, medication strength decreased 81% and medication cost decreased 78%.

Anderson JW. Meal replacement use patterns for patients losing > 100 pounds in a behavioral, low-energy-diet program. Obes Res 2004;12 suppl:A38.
This study reported on the dietary and exercise patterns of 65 patients who had lost > 100 lbs. Most patients consumed only HMR meal replacement shakes initially but slowly increased the intake of HMR entrees and nutrition bars.

Major A, Anderson JW. An adolescent weight reduction program including meal replacements and parental involvement decreases body weight and fat mass of obese adolescents. Obes Res 2004;12 suppl:A16.
Preliminary data indicated that adolescents lost an average of 25.1 lbs over 16 weeks. Those with parents participating in the program lost more weight and more body fat than those without parents participating.

Anderson J, Liu R, Conley S. Risk factor reductions with 100-pound weight losses: results for 75 medically treated morbidly obese individuals. Obes Res 2003;11 suppl:A91.
Results from 75 participants who lost > 100 lbs. found that the average weight loss was 136 lbs. or 39% of initial weight over 36 weeks. This weight loss significantly improved all measured CHD risk factors including, plasma glucose values, cholesterol, triglycerides, and HDL cholesterol.

Anderson JW, Ward AK, Gotthelf L, Early J. Response of obese adolescents to an intensive weight loss program. Am J Clin Nutr 2002;75:407S.
Forty-nine adolescents lost an average of 33.4 lbs. over an average of 18 weeks. For adolescents with a BMI >40, weight loss averaged 50 lbs.

Anderson JW, Konz EC, Frederich R, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr 2001;74:579-584.
Individuals who lost greater amounts of weight in shorter amounts of time (e.g., very low calorie diet) lost significantly more weight overall and kept off more of the weight than those following less intensive diets. Additionally, those who exercised more had significantly greater success with weight-loss maintenance than those who exercised less.

Gotthelf L, O’Brien B, Stifler L. Success in behavioral weight management program depends on treatment variables chosen. Obes Res 2001;9 suppl 3:181S.
Behavioral and weight change data from a total of 248 maintenance patients who were active in either 1995 or in 2000 were compared. Due to recent changes in the HMR Program, those who were enrolled in 2000 gained less weight in maintenance and participated in more lifestyle behaviors, such as physical activity, meal replacements, and vegetable/fruit intake.

Gotthelf L, O’Brien B, Stifler L. Accountability (attendance and phone calls) is critical for patient success in weight management program. Obes Res 2000;8 suppl 1:69S.
Data from 666 maintenance participants were analyzed to determine the impact of attendance and phone calls on success. Those who attended the program most often and made a greater number of structured phone calls were more successful with weight management and lifestyle behaviors than those who attended less often.

Gotthelf L, Ringie L, Young M. Greater improvement in medical risk factors with greater weight loss/maintenance compared to recommended 5-10%. Obes Res 2000;8 suppl 1:69S.
The average weight loss maintenance for a sample of 1,219 participants was 43.1 lbs. (17% of initial body weight) over 2 years. Compared to the standard of a 5-10% loss of initial body weight, those maintaining greater amounts of weight demonstrated significant improvements in medical risk factors.

Gotthelf L, Weithman C, O’Brien B. Use of meal replacements associated with greater success in weight maintenance treatment program. J Am Diet Assoc 2000;100 suppl:A-75.
In a sample of 666 participants, those who used > 14 meal replacements per week did better with weight maintenance and participated in more lifestyle behaviors (physical activity, vegetable/fruit intake, attended the program, and kept records) than those who used < 14 meal replacements per week.

Anderson JW, Vichitbandra S, Qian W, Kryscio RJ. Long-term weight maintenance after an intensive weight-loss program. J Am Coll Nutr 1999;18:620-627.
This prospective study documented an average weight loss of 65 lbs. for patients in a medically supervised HMR very-low-calorie diet program and reported follow-up data of up to seven years.

Shiffman ML, Kaplan GD, Brinkman-Kaplan V, Vickers FF. Prophylaxis against gallstone formation with ursodeoxyholic acid in patients participating in a very-low-calorie diet program. Ann Intern Med 1995;122:899-905.
Patients from 31 HMR programs participated in a clinical trial that showed ursodeoxycholic acid is highly effective in preventing gallstone formation during a very-low-calorie diet.

Anderson JW, Brinkman-Kaplan VL, Hamilton CC, Logan JE, Collins RW, Gustafson NJ. Food-containing hypocaloric diets are as effective as liquid-supplement diets for obese individuals with NIDDM. Diabetes Care 1994;17:602-604.
Forty individuals with type 2 diabetes, using either all meal replacements or meal replacements plus non-MR foods in an HMR medically supervised program, lost an average of 35 lbs. and improved glycemic, blood lipid, and blood pressure parameters.

Anderson JW, Brinkman-Kaplan VL, Lee H, Wood CL. Relationship of weight loss to cardiovascular risk factors in morbidly obese individuals. J Am Coll Nutr 1994;14:256-261.
Improvements in cardiovascular risk factors (serum lipids and blood pressure) were significantly and linearly related to the degree of weight loss for 80 morbidly obese patients in a medically supervised HMR program.

Anderson JW, Brinkman VL, Hamilton CC. Weight loss and 2-year follow-up for 80 morbidly obese patients treated with intensive very-low-calorie diet and an education program. Am J Clin Nutr1992;56:244-246S.
This follow-up study found that obese individuals in a medically supervised HMR program lost a substantial amount of weight, reduced risk factors, and were maintaining 48% of their weight loss two years after treatment.

Anderson JW, Hamilton CC, Brinkman-Kaplan V. Benefits and risks of an intensive very-low-calorie diet program for severe obesity. Am J Gastroenterol 1992;87:6-15.
This article reviewed the use of very low calorie diets and reported data for three samples of patients enrolled in an HMR program. Patients were maintaining approximately 56% of their initial weight loss two years after treatment.

Kaplan GD, Miller KC, Anderson JW. Comparative weight loss in obese patients restarting a supplemented very-low-calorie diet. Am J Clin Nutr 1992;56:290S-291S.
Patients restarting an HMR very-low-calorie diet (VLCD) program were found to have similar rates of weight loss- as well as significant net weight loss - suggesting that repeat VLCDs can be effective.

Anderson JW, Hamilton CC, Crown-Weber E, Riddlemoser M, Gustafson NJ. Safety and effectiveness of a multidisciplinary very-low-calorie diet program for selected obese individuals. J AmDiet Assoc 1991;91:1582-1584.
This study reported the results for the first 100 patients consecutively enrolled in an HMR very-low-calorie diet program (up to 42 month follow-up).

Results from the HMR at Home® Program

Befort CA, Donnelly JE, Sullivan DK, Ellerbeck EF, Perri MG. Group versus individual phone-based obesity treatment for rural women. Eat Behav 2010;11:11-17.
Rural women randomized to group phone-based treatment lost more weight (32.8 lbs) compared to those receiving individual treatment (20.9 lbs). 62% of those in the group condition achieved the 10% weight loss goal compared to 50% in the individual condition. Group treatment was also found to be more cost-effective.

Smith B, Van Walleghen E, Cook-Wiens G, Martin RN, Curry CR, Sullivan DK et al. Comparison of two self-directed weight loss interventions: limited weekly support vs. no outside support. Obes Res & Clin Pract 2009;3:149-157.
Participants were randomly assigned to the HMR at Home self-directed program using meal replacements with either limited weekly support or no additional support. Both groups lost substantial weight (17 lbs, 13 lbs. respectively) in 12 weeks indicating the success of both options.

Gotthelf L, Grant L. Automatic delivery of meal replacements a useful strategy for participants in a self-care weight management program. Obes 2009;17 suppl 2:S279.
Pilot data were collected from 391 randomly contacted participants using the HMR at Home Program. Those using automatic delivery of meal replacements lost twice as much weight as those not using auto delivery. Nearly 60% of participants in auto delivery stayed on the program, at some level, for 9 weeks or longer and over one-third were dieting for 3 months or longer. Automatic delivery of meal replacements is a simple operational
procedure that helps to reinforce the treatment.

Donnelly JE, Smith BK, Dunn L, Mayo MM, Jacobsen DJ, Stewart EE, et al. Comparison of a phone vs. clinic approach to achieve 10% weight loss. Int J Obes 2007;31:1270-1276.
Ninety-six men and women were randomly assigned to an HMR clinic, HMR phone program, or a control group. Both the clinic and phone groups lost significantly more weight at 12 weeks than the control group (28.0, 23.4, and .77 pounds respectively). At 6 months, the phone and clinic groups both lost about 28 lbs. demonstrating that a weight loss intervention delivered entirely over the phone is a viable alternative method to a traditional clinic intervention.

Grant L, Gotthelf L. Successful weight maintenance in a telephone-based treatment program. Obes Res 2004;12 suppl:A44.
This study documented preliminary results for 37 participants who successfully completed the weight loss phase of the HMR at Home Phone Support Program and transitioned to maintenance. Overall, in 26.4 weeks, these participants lost 25.6 lbs. or 12.1% of initial body weight.

Gotthelf L, Ringie L, Jacobsen D. Coaching a weight loss group over the telephone: a successful treatment option. Obes Res 2003;11 suppl:A84.
The average weight loss for 55 participants who completed six weeks of the HMR at Home Phone Support Program program was 16.69 lbs. Overall, these data are comparable to the weight loss in the clinic-based program.

Weithman C, Gotthelf L, Ringie L. Increasing options for treatment: leading weight management groups via telephone. J Am Diet Assoc 2003;103 suppl 1:A-37.
This study extended earlier findings by providing the HMR at Home Phone Support Program in groups over the phone. The average weight loss for those completing the six week program was 17.2 lbs. or 7.5% of initial body weight.

Gotthelf L, Ringie L, Solie SA. Weight loss program via telephone coaching: a successful treatment option. J Am Diet Assoc 2002;102 suppl 2:A-24.
Data from a pilot study of a one-on-one, phone-based program indicated that the average weight loss was 15.8 lbs. or 7.4% of initial body weight in six weeks.

HMR Program as a Treatment for Type 2 Diabetes and Pre-Diabetes

Grant L, Gotthelf L. Patients with pre-diabetes who lose greater amounts of weight have greater reductions in medical risk factors and medication use. Obes 2009;17:suppl 2:S278.
Changes in medical risk factors and medication use were assessed in patients with pre-diabetes by weight change categories (> 100 lbs, 50-99 lbs, 1-49 lbs, weight gain). Although all weight loss categories had substantial health benefits, there was a dose-response relationship between weight loss and health changes with those losing the most weight having the greatest changes. The percent on diabetes medications at follow-up
by weight loss category were: 0%, 1.8%, 6.3% and 10.5% respectively.

Grant L, Gotthelf L. Patients with diabetes who lose greater amounts of weight have greater reductions in medications and risk factors compared to those who lose modest amounts of weight. Obes 2007;15 suppl:A97.
Patients with diabetes who lost >20% of initial body weight (average of 89 lbs) were 2-3 times more likely to come off insulin, oral diabetes, cholesterol and blood pressure medications compared to patients who lost 5-10% of initial weight.

Smith B, Daly A, Gotthelf L, Schmelzle K, Donnelly JE. Decrease in medication usage in type 2 diabetics during very-low-calorie and low-calorie diets. Obes 2006;14 suppl:A170.
29 patients who lost weight on a very-low-calorie diet decreased daily oral diabetes medications by 57% and total daily medications by 41%. Those patients (n = 16) who used a low-calorie diet decreased daily oral diabetes medications by 45% and total daily medications by 26%.

Anderson JW, Furlow EA. Weight loss associated with greater reductions in plasma glucose values with impaired fasting glucose than with normoglycemic for obese individuals. Obes 2006;14suppl:A167.
Weight loss in obese and severely obese patients was accompanied by substantially larger improvements in cardiovascular risk factors in those with impaired fasting glucose or high normal fasting plasma glucose than with normoglycemia.

Gotthelf L, Grant L. Weight management program substantially reduces risk factors for those with pre-diabetes. Obes Res 2005;13 suppl:A83.
This study documented lifestyle changes and medical outcomes of 175 maintenance participants who entered the HMR program with pre-diabetes (impaired fasting plasma glucose). The average maintenance of weight loss was 47 lbs. after an average of 2.6 years. Lifestyle changes were associated with highly significant reductions in all measured medical risk factors, including fasting blood glucose, total cholesterol/HDL ratio, triglycerides, and blood pressure.

Smith B, Daly A, Roling L, Gotthelf L, Schmelzle K, Donnelly JE. Decrease in medication usage in type 2 diabetics during a very-low-calorie-diet. Obes Res 2005;13 suppl:A81.
Eighteen participants with type 2 diabetes lost an average of 45.9 lbs. in 12 weeks, decreased medication usage, and improved fasting blood glucose and HbA1c. All eight participants who had used insulin daily at program entry had discontinued insulin at program exit.

Konz E, Reynolds R, Conley S, Anderson J. Eects of weight loss on body composition
measurements in diabetic versus non-diabetic women. Obes Res 2005;13 suppl:A126.
Women with diabetes lost as much body weight in a 16 week weight loss study as did women without diabetes but did not lose as much body fat.

Konz E, Reynolds R, Conley S, Anderson J. Effects of weight loss on metabolic adaptations in diabetic versus non-diabetic women. Obes Res 2005;13 suppl:A137.
After completing 16 weeks of weight loss, women with diabetes lost equivalent amounts of weight compared to those without diabetes but did have alteration in hormone levels, including insulin, leptin, ghrelin, adiponectin and resistin.

Reynolds LR, Anderson JW. Practical office strategies for weight management of the obese diabetic individual. Endocr Pract 2004;10:153-159.
This summary article reviews strategies for enhancing lifestyle change and weight loss in the obese individual with type 2 diabetes. In particular, the strategies used in the HMR Program, such as the use of meal replacements, increased intake of vegetables and fruits, and physical activity, are included.

Anderson JW, Kendall CWC, Jenkins DJA. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr 2003;22:331-339.
This analysis of data concluded that weight management may be the most important therapeutic task for most obese individuals with type 2 diabetes. A weight loss of 10% of initial body weight dramatically improves glycemic control and reduces lipids and blood pressure.

Reynolds LR, Konz EC, Frederich RC, Anderson JW. Rosiglitazone amplifies the benefits of lifestyle intervention measures in long-standing type 2 diabetes mellitus. Diabetes Obes Metab 2002;4:270-275.
Obese patients who had type 2 diabetes for an average of 17 years had substantial reductions in cardiovascular risk factors (such as weight, blood pressure, HbA1c, and lipids) after participating in an HMR Healthy Solutions program.

Reynolds R, Anderson JW, O’Brien B, Gotthelf L. Obese diabetic and nondiabetic individuals lose similar amounts of weight in a medically supervised behavioral weight loss program. Obes Res 2004;12 suppl:A40.
The results of this study demonstrated that participants with type 2 diabetes can successfully participate in a medically supervised behavioral program. Patients lost an average of 18% of their body weight over a 21-week period.

Konz EC, Anderson JW, Reynolds LR. Low-energy diet effects on percentage weight and body fat changes in women with and without type 2 diabetes. Obes Res 2004;12 suppl:A36.
After 16 weeks of weight loss, preliminary data indicated no significant difference in the percent weight loss between individuals with or without type 2 diabetes. Those with diabetes lost significantly less percent body fat compared to those without diabetes.

Weithman C, Gotthelf L, Grant L, O’Brien B. Patients at risk for type 2 diabetes substantially improve risk factors in an intensive weight management treatment program. J Am Diet Assoc 2004;104 suppl 2:A-24.
Data from 150 maintenance patients who entered the HMR program at-risk for diabetes indicated that participants were maintaining an average weight loss of 38 lbs. or 15% of initial body weight at an average of 3 years. Only 3.4% were taking oral diabetes medications at follow-up.

Gotthelf L, Ringie L. Patients with type 2 diabetes in weight management program have significant improvement in risk factors. Obes Res 2001;9 suppl 3:181S.
Data from 57 maintenance patients entering the program with type 2 diabetes but not using medications were analyzed. The average weight loss being maintained was 58 lbs. or 21% of initial body weight after an average of more than two years. There were significant changes in medical risk factors, including fasting blood glucose, total cholesterol/HDL ratio, triglycerides, and blood pressure.

Gotthelf L, Ringie L, Weithman C. Weight management program improves risk factors for diabetic patients. J Am Diet Assoc 2001;101 suppl:A-18.
Data from 65 maintenance patients who had entered with a diagnosis of type 2 diabetes found that the average weight loss being maintained was 53 lbs. or 19% of initial body weight over an average of 1.8 years.

Collins RW, Anderson JW. Medication cost savings associated with weight loss for obese noninsulin-dependent diabetic men and women. Prev Med 1995;24:369-374.
Significant short-and long-term savings in prescription costs were obtained following a 12-week, 800-calorie HMR weight management program for obese individuals with type 2 diabetes.

HMR Meal Replacements: Composition and Use

Sullivan DK, Legowski PA, Jacobsen DJ, Heelan KAS, Johnson SL, Donnelly JE. A low-fat afterschool snack improves the nutritional quality of elementary school children’s diets. J Am Diet Assoc 2002;102:707-709.
Use of a low-fat, fortified HMR ice cream product three days a week for four weeks resulted in improved nutritional quality of elementary schoolchildren’s diet, including increased protein, calcium, iron, and decreased fat.

Bryner RW, Ullrich IH, Sauers J, Donley D, Hornsby G, Kolar M, Yeater R. Effects of resistance vs. aerobic training combined with an 800 calorie liquid diet on lean body mass and resting metabolic rate. J Am Coll Nutr 1999;18:115-121.
The addition of an intensive, high volume resistance training program resulted in preservation of lean body weight and resting metabolic rate during weight loss with a very-low-calorie diet using HMR meal replacements.

Perna F, Bryner R, Donley D, Kolar M, Hornsby G, Sauers J, et al. Eect of diet and exercise on quality of life and fitness parameters among obese individuals. JEP online 1999;2 (no. 2). 
Individuals who participated in an aerobic or resistance training program while using a very-low-calorie diet of HMR meal replacements experienced a greater quality of life than control patients.

Vazquez JA, Kazi, Madani N. Protein metabolism during weight reduction with very-low-energy diets: evaluation of the independent effects of protein and carbohydrate on protein sparing. Am J Clin Nutr 1995;62:93-103.
Carbohydrate and protein were found to have independent but additive protein-sparing effects during weight reduction.

Donnelly JE, Jacobsen DJ, Jakicic JM, Whately JE. Very low calorie diet with concurrent versus delayed and sequential exercise. Int J Obes 1994;18:469-475.
No advantage was found for delaying the onset of an exercise regimen during weight loss with a very-low-calorie diet (VCLD) using HMR meal replacements. Exercise, therefore, can be started concurrently with a VLCD.

Donnelly JE, Jacobsen DJ, Whately JE. Influence of degree of obesity on loss of fat-free mass during very-low-energy diets Am J Clin Nutr 1994;60:874-878.
This study examined data from women who lost an average of 46 lbs. using HMR meal replacements for 12 weeks. It was found that an increased level of obesity does not provide protection against the loss of fat free mass compared to lesser degrees of obesity.

Donnelly JE, Sharp T, Houmard J, Carlson MG, Hill JO, Whately JE, Israel RG. Muscle hypertrophy with large-scale weight loss and resistance training. Am J Clin Nutr 1993;58:561-565.
Weight training prevented muscle wasting during a very-low-calorie diet using HMR meal replacements that obtained large-scale weight losses.

Donnelly J, Pronk N, Jacobsen D, Pronk S, Jakicic J. Effects of a very-low-calorie diet and physicaltraining regimens on body composition and resting metabolic rate in obese females. Am J Clin Nutr 1991;54:56-61.
No differences were found in the effects of exercise combined with a very-low-calorie (VLCD) diet using HMR meal replacements compared to a VLCD alone in terms of preserving fat-free mass.