NCT03622086|Completed
Foundations of Fitness Program Pilot
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
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Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
Sponsor study identifier
interventional
29
1 country
1
Study Start
July 12, 2018
Actual (reported)Primary Completion
June 12, 2019
Actual (reported)Study Completion
June 12, 2019
Actual (reported)Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer. Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this. Clinical-community partnerships are well-positioned to address this care gap. This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting. In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic. Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase. The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change. A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 12, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2018
Actual (reported)July 18, 2018
Actual (reported)August 9, 2018
Actual (reported)June 12, 2019
Actual (reported)June 12, 2019
Actual (reported)Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
Programmatic feasibility will be defined as delivery of 100% of the sessions with 80% of children attending ≥75% of sessions and 80% completing pre- and post-assessments.
24 weeks
Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
24 weeks
Program Eligibility rate
Calculated using the following formula: \[# screen positive / # screened for inclusion\].
24 weeks
Program Enrollment rate
Body Mass Index Percentile
48 weeks
Strength Assessment
24 weeks
Health Habits Survey
24 weeks
Subjective Health and Quality of Life Score
24 weeks
Sense of Belonging in Fitness Program Score
24 weeks
Staff program adoption
24 weeks
Fidelity to planned program
24 weeks
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review. Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families. Content will be offered in a context that supports self-esteem and behavior change. The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight \& Wellness Center research core.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Auden C McClure, MD MPH
Dartmouth-Hitchcock Medical Center
29 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2018
First Posted
August 9, 2018
Study Start
July 12, 2018
Actual (reported)Active Recreation Through Community-Healthcare Engagement Study
Calculated using the following formula: \[# enrolled / (# screen positive \& eligible)\]. We will assess reasons for dropout/non-adherence.
24 weeks
Program Completion rate
Calculated using the following formula: (# completing all sessions / # enrolled).
24 weeks
Assessment Completion rate
Calculated using the following formula: (# completing all assessments / # enrolled).
24 weeks
Participant Satisfaction Survey
A 12 item survey at program conclusion will assess patient satisfaction with program elements (overall, class sessions, staff, assessments) using Likert scales (1-5 point scale - very dissatisfied=1 to very satisfied=5).
24 weeks
Contact the study team to confirm eligibility.
Primary Completion
June 12, 2019
Actual (reported)Study Completion
June 12, 2019
Actual (reported)Last Updated
July 10, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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