Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

Child Obesity Clinical Trial

— CONNECT  

Official title:

Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206529
• Other study ID #: 211098
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: October 11, 2017
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Social Network Engagement+Std Treatment

• Standard Treatment
Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Behavioral Skill Assessment	Process measure of parental use of skills taught during intervention	20 weeks after baseline
Other	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
Primary	Child BMI Z-score		20 weeks after baseline
Primary	Child BMI Z-score		One year post-treatment
Secondary	Peds QL (child self-report and parent report)	Pediatric Quality of Life Score	20 weeks after baseline
Secondary	Parent BMI	Intervention is aimed at the parent-child dyad, so parent weight status is assessed.	20 weeks after baseline
Secondary	Peds QL (child self-report and parent report)	Pediatric Quality of Life Score	One year post-treatment
Secondary	Parent BMI	Intervention is aimed at the parent-child dyad, so parent weight status is assessed.	One year post-treatment