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Completed

NCT Number: NCT02724839

Supporting Together Exercise and Play and Improving Nutrition

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group nutrition sessions

Behavioral

The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).

Other names: Peer-led Group Sessions

Fitbit

Device

Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.

Primary outcomes

  1. Attendance

    Time frame: Baseline, 3 months

    Evaluation of participant attendance in each arm.

  2. Overall Satisfaction With Group Nutrition Sessions

    Time frame: 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.

  3. Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.

    Time frame: 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.

Secondary outcomes

  1. PedsQL (Pediatric Quality of Life Inventory)

    Time frame: 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.

  2. BMI Z-Score

    Time frame: 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.

  3. Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)

    Time frame: baseline, 3 months

    The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.

  4. Child Self-efficacy Related to Physical Activity

    Time frame: 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

  5. Child Intention to be Active

    Time frame: 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.

  6. Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care

Acronym: STEP IN

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2016
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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