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Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
This study is ongoing, but not recruiting participants.
Sponsored by: Boston Medical Center
Information provided by: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00207519
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Behavioral: weekly behavioral modification group
Behavioral: liquid meal replacements
Phase I

MedlinePlus related topics: Obesity Obesity in Children
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Include laboratory parameters such as lipids and HbA1c.

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: August 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207519

Locations
United States, Massachusetts
Boston University Medical
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Caroline M Apovian, MD Boston University
  More Information

Publications:
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.
Troiano RP, Flegal KM. Overweight children and adolescents: description, epidemiology, and demographics. Pediatrics. 1998 Mar;101(3 Pt 2):497-504. Review.
Strauss RS, Pollack HA. Epidemic increase in childhood overweight, 1986-1998. JAMA. 2001 Dec 12;286(22):2845-8.
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.
Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998 Mar;101(3 Pt 2):518-25. Review.
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.
Ebbeling CB, Pawlak DB, Ludwig DS. Childhood obesity: public-health crisis, common sense cure. Lancet. 2002 Aug 10;360(9331):473-82. Review.
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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.
Strauss RS, Knight J. Influence of the home environment on the development of obesity in children. Pediatrics. 1999 Jun;103(6):e85.
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.
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.
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. No abstract available.
Devaney BL, Gordon AR, Burghardt JA. Dietary intakes of students. Am J Clin Nutr. 1995 Jan;61(1 Suppl):205S-212S.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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Brownell, KD. The LEARN Program for Weight Control. Dallas, TX: American Health Publishing: 1998.

Study ID Numbers: H-24640
Study First Received: September 13, 2005
Last Updated: June 1, 2007
ClinicalTrials.gov Identifier: NCT00207519  
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
overweight
obesity
adolescent

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 16, 2009