Bone Health of Obese Adolescents During Weight Loss

NCT00609713 | Completed

• 2 other identifiers: 2006-10-49761R01HD049701-01A2
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this proposal is to understand the impact of obesity and obesity treatment on bone health during adolescence and how to preserve it. The recent pediatric obesity epidemic raises important clinical and public health questions about the effects of childhood-onset obesity and its treatment on bone health. Osteoporotic fractures are a major cause of morbidity and mortality in the aged, and peak bone mass (PBM), achieved shortly after puberty, is a key determinant of bone strength and lifetime fracture risk. Given the current obesity epidemic, obesity treatment during adolescence will continue to be necessary. The benefits of pediatric obesity treatment are unquestionable. However, the potential detrimental effects of weight loss on bone density and dimensions are not known in adolescents and are the focus of this proposal. This study will focus on the impact of pediatric-onset obesity and its treatment on bone health, using two approaches: comparing obese and non-obese adolescents and comparing obese adolescents before and after weight loss. We hypothesize that (a) compared to non-obese controls, obese adolescents have stronger bones, and that (b) bone strength of obese adolescents decreases during weight loss compared to usual care, which would suggest a need to promote bone health during successful weight loss in obese adolescents.

Conditions

Pediatric Obesity

Keywords

Child; Obesity

Outcome Measures

Primary Outcomes (1)

• Quantitative computerized tomography (pQCT)

  Base line, 6 months, 12 months

Study Arms (2)

1

EXPERIMENTAL

Comprehensive 12-month family-based obesity treatment with separate adolescents and parents group sessions

Behavioral: Comprehensive behavioral weight control program

2

ACTIVE COMPARATOR

Individual 12-month nutrition education program

Other: Individual 12-month nutrition education program

Interventions

Comprehensive behavioral weight control program BEHAVIORAL

Participants will meet weekly for 12 weeks, then every other week for 12 weeks, and once a month thereafter through week 52. Adolescents and parents will receive manuals that provide lessons and homework assignments for each meeting. The program for the first 22 weeks includes the following topics: 1) the causes of obesity; 2) components of healthy nutrition; 3) self-monitoring of calories, physical activity, and inactivity; 4) stimulus control procedures; 5) coping with high-risk social or psychological situations that trigger excess eating; 6) increasing physical activity; and 7) minimizing inactivity. At each session, participants will submit their self-monitoring diaries and completed homework. Incentives for completion of self-monitoring tasks are an integral part of the behavior modification program and a small gift certificate will be given to subjects for successful completion at each intervention session.

1

Individual 12-month nutrition education program OTHER

The other half of the participants (44 subjects) will be randomized to this arm of the intervention (usual care), which will also start in five waves. In contrast to the comprehensive behavioral weight control program, the nutrition education program will take place through individual appointments with a clinical dietician to reflect usual care and mimic the present approach used for the treatment of obese adolescents at the Children's Hospital of Philadelphia (CHOP) Nutrition Consultation. Parents will be required to take part in the consultations. The first consultation will last 60 minutes and the following consultations of 30 minutes will take place once a month for the first six months, then every other month for the second six months, as is the usual practice in our clinical setting.

2

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Eligible participants will be 10.0 to 14.9 years of age, with a body mass index (BMI) above the 97th percentile for age (\~ +1.88 SD) and below +3.00 SD or less than 300 lb (\~ 136 kg), whichever is lower.

You may not qualify if:

• Syndromic or secondary obesity,
• Developmental delay requiring special education,
• Depression, psychosis,
• Eating disorders that involve insufficient or excessive food intake, such as anorexia nervosa or bulimia,
• Orthopedic problems interfering with moderate to vigorous physical activity,
• Diabetes,
• Polycystic ovary syndrome,
• History of systemic corticosteroids use for more than three months cumulatively, use of immunomodulators, anticonvulsivants, weight loss medications (including diet supplements) and any other medications, or chronic conditions that could interfere with the intervention or with bone health.
• Weight loss in the preceding six months of 5% or more, participation in another weight loss program,
• Cigarette smoking (smoking and smoking cessation can affect weight and bones),
• Sexual activity without contraception and/or pregnancy,
• Subjects without a primary care provider or with a provider unwilling to provide to the research team medical information on the child will be excluded.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Babette Zemel, PhD

  CHOP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 7, 2008
• Study Start: January 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

US (1)