Family Based Interventions: Preschool Children and Parent

NCT ID: NCT00024843

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2003-08-31

Brief Summary

To assess the efficacy of a 2-year family-based weight prevention program in a cohort of overweight preschool children and overweight parent pairs.

Detailed Description

BACKGROUND:

The proposal targets a population of individuals of great public health importance who are of high risk for weight gain: pre-school children of overweight parents. Family-based interventions are both theoretically and functionally reasonable approaches for use with these subjects, and the choice to focus on both increased physical activity and healthier food choices in the context of the family's environment is appropriate. The decision to include weight management outcomes on the parent as secondary endpoint is strategically wise and may provide important insights into the process of weight management. A broad array of data is to be collected and strong justification is provided for the inclusion of each.

The study is in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled "Innovative Approaches to the Prevention of Obesity". The resulting grant was later reassigned to the National Heart, Lung, and Blood Institute.

DESIGN NARRATIVE:

Approximately fifty child/parent pairs were recruited and randomized evenly to one of two groups: usual care versus an intervention focused on diet and activity strategies that included weekly group visits (24 weeks), biweekly group visits for parents (12 weeks), monthly group visits for parents (6 months) and quarterly group visits (12 months). Cognitive-behavioral therapy was used to guide interventions, which focussed on empowering a parent as the primary medium by which lifestyle changes were made. Major data collection at baseline, twelve, and 24 months included measures of weight; food and activity records; activity monitor recordings; biopsychosocial profiles; blood lipids, glucose, and insulin; process measures; parenting behavior; and child behavior. The primary study outcome measure was age- and gender-appropriate changes in BMI (expressed as a binomial response). Additional outcomes of particular interest were weight changes in the parent, diet and physical activity levels, parenting skills, and biopsychosocial measures.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Conditions

Cardiovascular Diseases; Heart Diseases; Obesity

Eligibility Criteria

Inclusion Criteria

No eligibility criteria

• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Sachiko St. Jeor

Role:

University of Nevada, Las Vegas

References

St Jeor ST, Perumean-Chaney S, Sigman-Grant M, Williams C, Foreyt J. Family-based interventions for the treatment of childhood obesity. J Am Diet Assoc. 2002 May;102(5):640-4. doi: 10.1016/s0002-8223(02)90146-x. No abstract available.

Reference Type: BACKGROUND

PMID: 12008987 (View on PubMed)

Other Identifiers

R01HL065133

Identifier Type: NIH

Identifier Source: secondary_id

View Link

988

Identifier Type: -

Identifier Source: org_study_id