Supporting Together Exercise and Play and Improving Nutrition

Not Applicable

Completed

Conditions: Obesity

Interventions: Behavioral: Group nutrition sessions
Device: Fitbit

Registration Number: NCT02724839

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary: The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.

Detailed Description: In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity. The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

Inclusion Criteria

Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
BMI is greater than 85th%ile for age and sex
English speaking
have access to a computer/internet or a smart phone (for uploading Fitbit data)

Exclusion Criteria

Have been seen in a weight management clinic within the last 2 years
prescribed an atypical antipsychotic
non-ambulatory

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monthly Arm	Group nutrition sessions	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place monthly.
Weekly	Fitbit	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place weekly.
Biweekly Arm	Fitbit	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place biweekly.
Biweekly Arm	Group nutrition sessions	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place biweekly.
Monthly Arm	Fitbit	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place monthly.
Weekly	Group nutrition sessions	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place weekly.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.	Baseline, 3 months	Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Overall Satisfaction With Group Nutrition Sessions	Baseline, 3 months	Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
Attendance	Baseline, 3 months	Evaluation of participant attendance in each arm.

Secondary Outcome Measures

Name	Time	Method
PedsQL (Pediatric Quality of Life Inventory)	Baseline, 3 months	Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life.
Child Intention to be Active	baseline, 3 months	Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al. This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active.
Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily	Baseline, 3 months	Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
BMI Z-Score	Baseline, 3 months	BMI Z-scores compares child to age and sex matched peers. A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles. Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population.
Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)	baseline, 3 months	The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
Child Self-efficacy Related to Physical Activity	Baseline, 3 months	Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale. The range of values is 1 to 5, with lower values indicating higher self-efficacy