Clinical trial NCT03622086: Foundations of Fitness Program Pilot
Official title: Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Health Behavior
Body Mass Index
Self Esteem
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 29
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 7-13 years;
* BMI% ≥85th%;
* Regional pediatric medical home patient;
* English speaking child and parent/caregiver;

Exclusion Criteria:

* Physical or developmental limitation to participation as determined by referring provider

Primary outcomes:
measure: Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
timeFrame: 24 weeks
measure: Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
timeFrame: 24 weeks
measure: Program Eligibility rate
timeFrame: 24 weeks
measure: Program Enrollment rate
timeFrame: 24 weeks
measure: Program Completion rate
timeFrame: 24 weeks
measure: Assessment Completion rate
timeFrame: 24 weeks
measure: Participant Satisfaction Survey
timeFrame: 24 weeks
Secondary outcomes:
measure: Body Mass Index Percentile
timeFrame: 48 weeks
measure: Strength Assessment
timeFrame: 24 weeks
measure: Health Habits Survey
timeFrame: 24 weeks
measure: Subjective Health and Quality of Life Score
timeFrame: 24 weeks
measure: Sense of Belonging in Fitness Program Score
timeFrame: 24 weeks
measure: Self Esteem Score
timeFrame: 24 weeks
measure: Physical Activity Score
timeFrame: 24 weeks
measure: Cardio-capacity
timeFrame: 24 weeks
measure: Heart Rate
timeFrame: 24 weeks
measure: Blood Pressure
timeFrame: 24 weeks
measure: Waist Circumference
timeFrame: 24 weeks
measure: Perceived Athletic Competence Score
timeFrame: 24 weeks
Other outcomes:
measure: Staff program adoption
timeFrame: 24 weeks
measure: Fidelity to planned program
timeFrame: 24 weeks
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Auden C McClure, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: