search
Back to results

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

Primary Purpose

Child Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Social Network Engagement+Std Treatment
Standard Treatment
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Obesity focused on measuring obesity, child, weight management, behavioral, social networks, social support

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Social Network Engagement+Std Treatment

    Standard Treatment

    Arm Description

    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)

    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)

    Outcomes

    Primary Outcome Measures

    Child BMI Z-score
    Child BMI Z-score

    Secondary Outcome Measures

    Peds QL (child self-report and parent report)
    Pediatric Quality of Life Score
    Parent BMI
    Intervention is aimed at the parent-child dyad, so parent weight status is assessed.
    Peds QL (child self-report and parent report)
    Pediatric Quality of Life Score
    Parent BMI
    Intervention is aimed at the parent-child dyad, so parent weight status is assessed.

    Full Information

    First Posted
    July 21, 2014
    Last Updated
    October 11, 2017
    Sponsor
    Kaiser Permanente
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02206529
    Brief Title
    Enhancing Family Based Treatment of Childhood Obesity Through Social Networks
    Acronym
    CONNECT
    Official Title
    Enhancing Family Based Treatment of Childhood Obesity Through Social Networks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente

    4. Oversight

    Data Monitoring Committee
    No

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Child Obesity
    Keywords
    obesity, child, weight management, behavioral, social networks, social support

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Social Network Engagement+Std Treatment
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    Standard Treatment
    Arm Type
    Other
    Arm Description
    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)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Social Network Engagement+Std Treatment
    Other Intervention Name(s)
    SNE
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Treatment
    Other Intervention Name(s)
    FOCUS Intervention
    Intervention Description
    Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)
    Primary Outcome Measure Information:
    Title
    Child BMI Z-score
    Time Frame
    20 weeks after baseline
    Title
    Child BMI Z-score
    Time Frame
    One year post-treatment
    Secondary Outcome Measure Information:
    Title
    Peds QL (child self-report and parent report)
    Description
    Pediatric Quality of Life Score
    Time Frame
    20 weeks after baseline
    Title
    Parent BMI
    Description
    Intervention is aimed at the parent-child dyad, so parent weight status is assessed.
    Time Frame
    20 weeks after baseline
    Title
    Peds QL (child self-report and parent report)
    Description
    Pediatric Quality of Life Score
    Time Frame
    One year post-treatment
    Title
    Parent BMI
    Description
    Intervention is aimed at the parent-child dyad, so parent weight status is assessed.
    Time Frame
    One year post-treatment
    Other Pre-specified Outcome Measures:
    Title
    SSQ (Social Support Questionnaire-Short Form)
    Description
    Global social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.
    Time Frame
    20 weeks after baseline
    Title
    QRI (Quality of the Relationship Index)
    Description
    Relationship-specific social support measure, assessed as possible mediator of effect of intervention on primary and secondary outcomes.
    Time Frame
    20 weeks after baseline
    Title
    SPSI-R (Social Problem-Solving Index-for Research)
    Description
    Measure of parental skill in problem-solving, assessed as possible mediator of effect of intervention on primary and secondary outcomes.
    Time Frame
    20 weeks after baseline
    Title
    Behavioral Skill Assessment
    Description
    Process measure of parental use of skills taught during intervention
    Time Frame
    20 weeks after baseline
    Title
    WMSI (Weight Management Support Index)
    Description
    Measure of parental perceived social support related to weight management, assessed as possible mediator of primary and secondary outcomes.
    Time Frame
    20 weeks after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paula Lozano, MD MPH
    Organizational Affiliation
    Group Health Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

    We'll reach out to this number within 24 hrs