CONNECT: Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT02206529

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Child Obesity	Behavioral: Social Network Engagement+Std Treatment Behavioral: Standard Treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Child BMI Z-score [20 weeks after baseline]
Child BMI Z-score [One year post-treatment]

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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