Enhancing Family Based Treatment of Childhood Obesity Through Social Networks (CONNECT)

The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that will be integrated into a standard treatment program for childhood overweight. The investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its effectiveness compared with historical controls who received standard treatment. The historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629).

Study Overview

• Status: Completed
• Conditions: Child Obesity
• Intervention / Treatment: Behavioral: Social Network Engagement+Std Treatment; Behavioral: Standard Treatment

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria Children

• Age 7-13 years
• At or above the 85th percentile for age- and gender-specific BMI

Parents

• At least one overweight parent (BMI>25.0)

Parents and children

• English-speaking and at least at a second-grade reading level
• Live <50 miles from the treatment site.

Exclusion Children

• Conditions known to promote obesity (e.g., Prader-Willi),
• Participation in another weight control program
• Recently started taking weight-affecting medications (e.g., stimulants).

Parents and children

• Disability or illness that would preclude them from engaging in at least moderate-intensity physical activity,
• Current or prior diagnosed eating disturbance
• Thought disorder, suicidality, or substance abuse disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Social Network Engagement+Std Treatment; Social Network Engagement = content and activities to help the parent engage his/her social network in supporting healthy lifestyle behaviors. Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)	Behavioral: Social Network Engagement+Std Treatment; Other Names: SNE
Other: Standard Treatment; This comparator arm consists of historical controls, participants in the FOCUS trial who received standard treatment. Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)	Behavioral: Standard Treatment; Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629); Other Names: FOCUS Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Child BMI Z-score	20 weeks after baseline
Child BMI Z-score	One year post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peds QL (child self-report and parent report)	Pediatric Quality of Life Score	20 weeks after baseline
Parent BMI	Intervention is aimed at the parent-child dyad, so parent weight status is assessed.	20 weeks after baseline
Peds QL (child self-report and parent report)	Pediatric Quality of Life Score	One year post-treatment
Parent BMI	Intervention is aimed at the parent-child dyad, so parent weight status is assessed.	One year post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSQ (Social Support Questionnaire-Short Form)	Global social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.	20 weeks after baseline
QRI (Quality of the Relationship Index)	Relationship-specific social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.	20 weeks after baseline
SPSI-R (Social Problem-Solving Index-for Research)	Measure of parental skill in problem-solving, assessed as possible mediator of effect of intervention on primary and secondary outcomes.	20 weeks after baseline
Behavioral Skill Assessment	Process measure of parental use of skills taught during intervention	20 weeks after baseline
WMSI (Weight Management Support Index)	Measure of parental perceived social support related to weight management, assessed as possible mediator of primary and secondary outcomes.	20 weeks after baseline

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Paula Lozano, MD MPH, Group Health Research Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: obesity; child; weight management; social support; behavioral; social networks
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 211098