Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents

Obesity Clinical Trial

Official title:

The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207519
• Other study ID #: H-24640
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: February 10, 2009
• Start date: April 2003
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARNÒ Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow.

Subjects will return on a weekly basis for behavioral modification groups sessions in conjunction with the liquid meal replacement diet. Blood work and physical examinations will occur pre and post intervention.

Description:

In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile), a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. Parents will be encouraged to attend group sessions designed to include behavior modification, nutrition education, physical activity recommendations, and food demonstrations as a means of family support for the subject. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARN Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow. Subjects will return for 12 weekly group sessions.

For the purposes of this pilot study, mild hypertension is defined as a systolic blood pressure of >130 but <140 mm Hg and a diastolic blood pressure of >85 but <90 mm Hg. Dyslipidemia will be defined as a total cholesterol of >200 mg/dl, LDL >130 mg/dl, HDL <40 mg/dl for male subjects and <50 mg/dl for female subjects, and triacylglycerol of >150 mg/dl. Insulin resistance/diabetes shall be defined as a fasting glucose of >110 mg/dl.

Calculating Estimated Caloric Need:

Total caloric needs for subjects with a BMI >85th% for age and sex shall be calculated using the Basal Energy Expenditure multiplied by an Activity Factor (for an estimate of total energy requirements), then subtracting 250-500 calories (to achieve a 0.5 to 1 pound weight loss per week). Basal Energy Expenditure will be calculated by using the Harris-Benedict equation as follows:

Females = 655 + 4.4(wt. in lbs) + 4.3(ht. in inches) - 4.7(age in yrs) x AF Males = 66 + 6.2(wt. in lbs) +12.7(ht. in inches) - 6.8(age in yrs) x AF

Activity Factors (AF):

1.1 Restricted Activity 1.2 Sedentary (most commonly used) 1.3 Cardiovascular Activity 3x/wk

Ideal body weight is defined as:

Females = 100 lb for the first 5 ft + 5 lb for each inch over 5 ft Males = 106 lb for the first 5 ft + 6 lb for each inch over 5 ft

Subjects will be prescribed a meal plan consisting of 3 meals and 2 snacks per day. However, 2 of the 3 meals will be replaced with a liquid meal replacement which contains 220 kcal, 10 g. protein, 40 g. carbohydrate, 2.5-3 g. fat, and 5 g. dietary fiber as well as vitamin and mineral fortification. The third meal will be high in fruits, vegetables, whole grains, lean protein (30-45 g/day) and contain 600-900 kcal. Low-calorie snacks, to include additional fruit servings, will be encouraged. The meal replacements will be taken at a time the subject will be most compliant, i.e., if subject is a chronic breakfast skipper, a meal replacement will be added for the breakfast meal. All meal replacements will be provided to the subjects at no cost; subjects will complete an order form at each visit indicating flavor choices of vanilla, chocolate or strawberry for the liquid meal replacements. They will be offered the option of a meal replacement bar versus liquid meal replacement for only one of the meal replacements per day (220 kcal, 8 g. protein, 36 g. carbohydrate, 2 g. dietary fiber). These will be a choice of chocolate peanut or granola/fruit bars.

To identify and encourage dietary compliance, subjects will be provided with a food record and will be instructed to complete 3 food records per week, two week days and one weekend day, and to indicate the time of day and which type of meal replacement was consumed. This indication will be helpful in dietary instruction regarding time of day compliance is best for consuming the meal replacement. Subjects will also be instructed to return any unused meal replacements and labels from consumed meal replacements at their regularly scheduled visits as further identification of compliance to diet. A validated Youth and Adolescent Food Frequency Questionnaire or Adolescents Food Habits Checklist will be obtained at the beginning and end of the pilot study. Blood work and a physical exam will be performed pre and post intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• BMI >85th% for age and sex

• Weight gain over the last 6 months of >5% than expected on the growth curve

• 12-17 years of age

Exclusion Criteria:

• Subjects with intolerance to dairy products (e.g., lactose intolerance) will be excluded from entering into the study.

• Subjects must not have a history of clinically significant cardiac disease, congenital heart disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.

• Subjects must not have a history of anorexia nervosa, untreated hypothyroidism (TSH greater than 4.0 mU/L for a second generation test), malignancy, pathophysiologic or genetic syndromes associated with obesity (i.e., Cushing's syndrome, Turner's syndrome, Prader Willi syndrome), major psychiatric illness such as bi-polar disorder, ADD, major depression, bulimia, schizophrenia, or psychosis.

• Subjects may not participate in any weight management program, except for that in this study, during this pilot. Subjects may not use prescription or over-the-counter (or herbal) weight control medication during the trial.

• Subjects must not have a history of alcohol or drug addiction or substance abuse within the previous 2 years.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• weekly behavioral modification group

• liquid meal replacements

Locations

Country	Name	City	State
United States	Boston University Medical	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (27)

Alaimo K, McDowell MA, Briefel RR, Bischof AM, Caughman CR, Loria CM, Johnson CL. Dietary intake of vitamins, minerals, and fiber of persons ages 2 months and over in the United States: Third National Health and Nutrition Examination Survey, Phase 1, 1988-91. Adv Data. 1994 Nov 14;(258):1-28. — View Citation

Barlow SE, Dietz WH. Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services. Pediatrics. 1998 Sep;102(3):E29. — View Citation

Brownell, KD. The LEARN Program for Weight Control. Dallas, TX: American Health Publishing: 1998.

Csábi G, Török K, Jeges S, Molnár D. Presence of metabolic cardiovascular syndrome in obese children. Eur J Pediatr. 2000 Jan-Feb;159(1-2):91-4. — View Citation

Devaney BL, Gordon AR, Burghardt JA. Dietary intakes of students. Am J Clin Nutr. 1995 Jan;61(1 Suppl):205S-212S. — View Citation

Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998 Mar;101(3 Pt 2):518-25. Review. — View Citation

Ditschuneit HH, Flechtner-Mors M, Johnson TD, Adler G. Metabolic and weight-loss effects of a long-term dietary intervention in obese patients. Am J Clin Nutr. 1999 Feb;69(2):198-204. — View Citation

Ebbeling CB, Pawlak DB, Ludwig DS. Childhood obesity: public-health crisis, common sense cure. Lancet. 2002 Aug 10;360(9331):473-82. Review. — View Citation

Fagot-Campagna A, Pettitt DJ, Engelgau MM, Burrows NR, Geiss LS, Valdez R, Beckles GL, Saaddine J, Gregg EW, Williamson DF, Narayan KM. Type 2 diabetes among North American children and adolescents: an epidemiologic review and a public health perspective. J Pediatr. 2000 May;136(5):664-72. Review. — View Citation

Flechtner-Mors M, Ditschuneit HH, Johnson TD, Suchard MA, Adler G. Metabolic and weight loss effects of long-term dietary intervention in obese patients: four-year results. Obes Res. 2000 Aug;8(5):399-402. — View Citation

Heber D, Ashley JM, Wang HJ, Elashoff RM. Clinical evaluation of a minimal intervention meal replacement regimen for weight reduction. J Am Coll Nutr. 1994 Dec;13(6):608-14. — View Citation

Krebs-Smith SM, Cook A, Subar AF, Cleveland L, Friday J, Kahle LL. Fruit and vegetable intakes of children and adolescents in the United States. Arch Pediatr Adolesc Med. 1996 Jan;150(1):81-6. — View Citation

Leighty J, Greve L, Hembrooke T, Hood K, Hughes T, O'Brien P, Warden N, Styne D. Alterations in nutrient intake in 6-10 year old, severely obese children following a 12-week family centered integrated treatment program. Pediatric Research. 2001;49:P3-758.

McCarron DA, Oparil S, Chait A, Haynes RB, Kris-Etherton P, Stern JS, Resnick LM, Clark S, Morris CD, Hatton DC, Metz JA, McMahon M, Holcomb S, Snyder GW, Pi-Sunyer FX. Nutritional management of cardiovascular risk factors. A randomized clinical trial. Arch Intern Med. 1997 Jan 27;157(2):169-77. — View Citation

McDowell MA, Briefel RR, Alaimo K, Bischof AM, Caughman CR, Carroll MD, Loria CM, Johnson CL. Energy and macronutrient intakes of persons ages 2 months and over in the United States: Third National Health and Nutrition Examination Survey, Phase 1, 1988-91. Adv Data. 1994 Oct 24;(255):1-24. — View Citation

McDuffie JR, Calis KA, Uwaifo GI, Sebring NG, Fallon EM, Hubbard VS, Yanovski JA. Three-month tolerability of orlistat in adolescents with obesity-related comorbid conditions. Obes Res. 2002 Jul;10(7):642-50. — View Citation

Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. — View Citation

Pi-Sunyer FX, Maggio CA, McCarron DA, Reusser ME, Stern JS, Haynes RB, Oparil S, Kris-Etherton P, Resnick LM, Chait A, Morris CD, Hatton DC, Metz JA, Snyder GW, Clark S, McMahon M. Multicenter randomized trial of a comprehensive prepared meal program in type 2 diabetes. Diabetes Care. 1999 Feb;22(2):191-7. — View Citation

Quinn Rothacker D. Five-year self-management of weight using meal replacements: comparison with matched controls in rural Wisconsin. Nutrition. 2000 May;16(5):344-8. — View Citation

Rosenbloom AL, Joe JR, Young RS, Winter WE. Emerging epidemic of type 2 diabetes in youth. Diabetes Care. 1999 Feb;22(2):345-54. Review. — View Citation

Strauss RS, Knight J. Influence of the home environment on the development of obesity in children. Pediatrics. 1999 Jun;103(6):e85. — View Citation

Strauss RS, Pollack HA. Epidemic increase in childhood overweight, 1986-1998. JAMA. 2001 Dec 12;286(22):2845-8. — View Citation

Styne D, Greve L, Hembrooke T, Hood K, Hughes T, Leighty J, O'Brien P, Warden N. Anthropomorphic and biochemical results of a family centered integrated treatment program for severely obese children. Pediatric Research. 2001;49:P3-757.

Suarez FL, Zumarraga LM, Furne JK, Levitt MD. Nutritional supplements used in weight-reduction programs increase intestinal gas in persons who malabsorb lactose. J Am Diet Assoc. 2001 Dec;101(12):1447-52. — View Citation

Summerbell CD, Watts C, Higgins JP, Garrow JS. Randomised controlled trial of novel, simple, and well supervised weight reducing diets in outpatients. BMJ. 1998 Nov 28;317(7171):1487-9. — View Citation

Troiano RP, Flegal KM. Overweight children and adolescents: description, epidemiology, and demographics. Pediatrics. 1998 Mar;101(3 Pt 2):497-504. Review. — View Citation

Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome measures include for efficacy of intervention, height, weight, BMI, waist circumference, percent body fat, height Z-score, weight Z-score, BMI-Z score, degree of change in weight Z-score, BMI Z-score, and percent body.
Secondary	Include laboratory parameters such as lipids and HbA1c.