Family Weight Management Study

NCT00851201 | Completed

• 1 other identifier: R18DK075981
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to address the Healthy People 2010 obesity prevention objective. This study will test the effects of a comprehensive family weight management program on the BMI z-score of 7-12 year-old children with a BMI \> 85th percentile who receive primary care in a large municipal Bronx hospital. The intervention framework will draw on social marketing theory and the transtheoretical model of behavioral change to incorporate successful obesity prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will enroll (n =506) 7-12 year old children with a \> 85th BMI percentile, will compare the Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2)quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will add: 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a "toolbox" approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups. The study will determine if children randomized to the Experimental Intensive Intervention will have greater improvement in BMI change (z-scores) than those randomized to the Control Standard Intervention. The study will also evaluate the effects on the Experimental Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will address: Reach: How many of the eligible children/ families were referred and how many of those referred actually enrolled? We will use BMI data in the computerized medical records to evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when followed as planned? Adoption: How acceptable were the intervention(s) to the primary care medical team and the children/families in the pediatric clinics etc? (from process measures and post intervention surveys) Implementation: How many of the intervention activities were provided as planned? Quality control measures will be used to evaluate the integrity of the intervention(s). Maintenance: How much of the intervention effect is sustainable? Individual effects will be evaluated based on the 24 month follow data. Institutional effects evaluation will include the potential to maintain services using third-party coverage.

Conditions

Obesity; Diabetes

Keywords

children; obesity; weight loss; prevention; diabetes risk; cardiometabolic

Outcome Measures

Primary Outcomes (1)

• BMI percentile for age and sex, biomarkers e.g, glucose, insulin, lipids

  12 months after randomization

Secondary Outcomes (1)

• dietary intake, and physical activity measures

  12 months after randomization

Study Arms (2)

Standard Intervention

ACTIVE COMPARATOR

Behavioral: Standard intervention

Intensive lifestyle

EXPERIMENTAL

Behavioral: Intensive lifestyle

Interventions

Intensive lifestyle BEHAVIORAL

The intensive lifestyle intervention will include the standard intervention plus 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a "toolbox" approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups.

Intensive lifestyle

Standard intervention BEHAVIORAL

The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2) quarterly follow-up, 3) and a monthly newsletter.

Standard Intervention

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• BMI greater than 85th percentile for sex, age 7-12 years

You may not qualify if:

• health or condition that would interfere with study participation, unwilling or inability to provide parent/guardian consent or child ascent, intention to move from area

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

North Bronx Health Network

The Bronx, New York, 10461, United States

Location

Related Publications (5)

• Wylie-Rosett J, Isasi C, Soroudi N, Soroker E, Sizemore C, Groisman-Perelstein A, Bass J, Diamantis P, Ahmed T, Gandhi R. KidWAVE: Get Healthy Game--promoting a more healthful lifestyle in overweight children. J Nutr Educ Behav. 2010 May-Jun;42(3):210-2. doi: 10.1016/j.jneb.2009.12.003. No abstract available.

  PMID: 20434077 BACKGROUND

• Wright ND, Groisman-Perelstein AE, Wylie-Rosett J, Vernon N, Diamantis PM, Isasi CR. A lifestyle assessment and intervention tool for pediatric weight management: the HABITS questionnaire. J Hum Nutr Diet. 2011 Feb;24(1):96-100. doi: 10.1111/j.1365-277X.2010.01126.x. Epub 2010 Sep 30.

  PMID: 21210873 BACKGROUND

• Matthan NR, Wylie-Rosett J, Xue X, Gao Q, Groisman-Perelstein AE, Diamantis PM, Ginsberg M, Mossavar-Rahmani Y, Barger K, Lichtenstein AH. Effect of a Family-Based Intervention on Nutrient Biomarkers, Desaturase Enzyme Activities, and Cardiometabolic Risk Factors in Children with Overweight and Obesity. Curr Dev Nutr. 2019 Dec 2;4(1):nzz138. doi: 10.1093/cdn/nzz138. eCollection 2020 Jan.

  PMID: 31922084 DERIVED

• Wylie-Rosett J, Groisman-Perelstein AE, Diamantis PM, Jimenez CC, Shankar V, Conlon BA, Mossavar-Rahmani Y, Isasi CR, Martin SN, Ginsberg M, Matthan NR, Lichtenstein AH. Embedding weight management into safety-net pediatric primary care: randomized controlled trial. Int J Behav Nutr Phys Act. 2018 Jan 22;15(1):12. doi: 10.1186/s12966-017-0639-z.

  PMID: 29357894 DERIVED

• Khan UI, McGinn AP, Isasi CR, Groisman-Perelstein A, Diamantis PM, Ginsberg M, Wylie-Rosett J. Differences in Cardiometabolic Risk between Insulin-Sensitive and Insulin-Resistant Overweight and Obese Children. Child Obes. 2015 Jun;11(3):289-96. doi: 10.1089/chi.2014.0112. Epub 2015 Mar 16.

  PMID: 25774664 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Judith Wylie-Rosett, EdD, RD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (1)