Supporting Together Exercise and Play and Improving Nutrition (STEP IN)
13 november 2020 uppdaterad av: Children's Hospital Medical Center, Cincinnati
Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45229
- Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 år till 12 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Biweekly Arm
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.
|
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).
Andra namn:
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.
|
|
Experimentell: Monthly Arm
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.
|
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).
Andra namn:
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.
|
|
Experimentell: Weekly
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.
|
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).
Andra namn:
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Attendance
Tidsram: Baseline, 3 months
|
Evaluation of participant attendance in each arm.
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Baseline, 3 months
|
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Overall Satisfaction With Group Nutrition Sessions
Tidsram: 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.
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Baseline, 3 months
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Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
Tidsram: 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.
|
Baseline, 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PedsQL (Pediatric Quality of Life Inventory)
Tidsram: 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.
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Baseline, 3 months
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BMI Z-Score
Tidsram: 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.
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Baseline, 3 months
|
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Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
Tidsram: baseline, 3 months
|
The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
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baseline, 3 months
|
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Child Self-efficacy Related to Physical Activity
Tidsram: 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
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Baseline, 3 months
|
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Child Intention to be Active
Tidsram: baseline, 3 months
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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.
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baseline, 3 months
|
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Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
Tidsram: 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.
|
Baseline, 3 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Kristen A Copeland, Children's Hospital Medical Center, Cincinnati
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2015
Primärt slutförande (Faktisk)
1 oktober 2018
Avslutad studie (Faktisk)
1 december 2018
Studieregistreringsdatum
Först inskickad
14 mars 2016
Först inskickad som uppfyllde QC-kriterierna
25 mars 2016
Första postat (Uppskatta)
31 mars 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 november 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 november 2020
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2015-3406
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
This was a small, iterative feasibility study as a precursor to a larger clinical trial.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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