Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents

NCT00207519 | Completed Phase 1

• 1 other identifier: H-24640
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Keywords

overweight; obesity; adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Include laboratory parameters such as lipids and HbA1c.

Interventions

weekly behavioral modification group BEHAVIORAL

liquid meal replacements BEHAVIORAL

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI \>85th% for age and sex
• Weight gain over the last 6 months of \>5% than expected on the growth curve
• years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston University Medical

Boston, Massachusetts, 02118, United States

Location

Related Publications (27)

• 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. doi: 10.1001/jama.288.14.1728.

  PMID: 12365956 BACKGROUND

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

  PMID: 12224656 BACKGROUND

• Strauss RS, Pollack HA. Epidemic increase in childhood overweight, 1986-1998. JAMA. 2001 Dec 12;286(22):2845-8. doi: 10.1001/jama.286.22.2845.

  PMID: 11735760 BACKGROUND

• 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. doi: 10.1542/peds.102.3.e29.

  PMID: 9724677 BACKGROUND

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

  PMID: 12224658 BACKGROUND

• 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. doi: 10.1067/mpd.2000.105141.

  PMID: 10802501 BACKGROUND

• Ebbeling CB, Pawlak DB, Ludwig DS. Childhood obesity: public-health crisis, common sense cure. Lancet. 2002 Aug 10;360(9331):473-82. doi: 10.1016/S0140-6736(02)09678-2.

  PMID: 12241736 BACKGROUND

• Rosenbloom AL, Joe JR, Young RS, Winter WE. Emerging epidemic of type 2 diabetes in youth. Diabetes Care. 1999 Feb;22(2):345-54. doi: 10.2337/diacare.22.2.345.

  PMID: 10333956 BACKGROUND

• Csabi G, Torok K, Jeges S, Molnar D. Presence of metabolic cardiovascular syndrome in obese children. Eur J Pediatr. 2000 Jan-Feb;159(1-2):91-4. doi: 10.1007/pl00013812.

  PMID: 10653338 BACKGROUND

• 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. doi: 10.1056/NEJM199709253371301.

  PMID: 9302300 BACKGROUND

• Strauss RS, Knight J. Influence of the home environment on the development of obesity in children. Pediatrics. 1999 Jun;103(6):e85. doi: 10.1542/peds.103.6.e85.

  PMID: 10353982 BACKGROUND

• 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. doi: 10.1038/oby.2002.87.

  PMID: 12105286 BACKGROUND

• 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.

  PMID: 10141689 BACKGROUND

• Devaney BL, Gordon AR, Burghardt JA. Dietary intakes of students. Am J Clin Nutr. 1995 Jan;61(1 Suppl):205S-212S. doi: 10.1093/ajcn/61.1.205S.

  PMID: 7832167 BACKGROUND

• 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. doi: 10.1001/archpedi.1996.02170260085014.

  PMID: 8542012 BACKGROUND

• 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. doi: 10.1038/oby.2000.48.

  PMID: 10968732 BACKGROUND

• 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. doi: 10.1016/s0899-9007(99)00280-4.

  PMID: 10793302 BACKGROUND

• 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. doi: 10.1093/ajcn/69.2.198.

  PMID: 9989680 BACKGROUND

• 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. doi: 10.1080/07315724.1994.10718456.

  PMID: 7706595 BACKGROUND

• 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.

  PMID: 9009974 BACKGROUND

• 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. doi: 10.2337/diacare.22.2.191.

  PMID: 10333932 BACKGROUND

• 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. doi: 10.1136/bmj.317.7171.1487.

  PMID: 9831574 BACKGROUND

• 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. doi: 10.1016/S0002-8223(01)00349-2.

  PMID: 11762740 BACKGROUND

• 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.

  PMID: 10138938 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline M Apovian, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: January 1, 2009
• Last Updated: February 11, 2009

Record last verified: 2009-02

Locations

US (1)