Foundations of Fitness Program Pilot

Study Overview
=================
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.

Official Title
-----------------
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity

Conditions
-----------------
Pediatric Obesity, Health Behavior, Body Mass Index, Self Esteem

Intervention / Treatment
-----------------
* Other: Foundations of Fitness Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7-10 years old<br>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. | Other: Foundations of Fitness Program<br>* 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.<br>|
| Experimental: 11-13 years old<br>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. | Other: Foundations of Fitness Program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index Percentile | Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2) and then BMI percentile (%) using Center for Disease Control 2000 standards. | 48 weeks | 
| Strength Assessment | Assessed through 5 exercises including: leg extension, leg curl, lap pull down, shoulder press, chest press. Units for all are number of repetitions per minute at a fixed mass (lbs). | 24 weeks | 
| Health Habits Survey | The Weight & Wellness Center Health Habits Survey assesses diet, activity, media and sleep behaviors through 46 individual survey questions with variable response categories (for example, overall physical activity is assessed using a 0-5 point Likert scale with higher score related to better physical activity level:  Overall my physical activity level is: Poor=0 - Excellent=5) | 24 weeks | 
| Subjective Health and Quality of Life Score | The Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health 7 survey (child and parent proxy) is a 7-question survey (Score 7-35) capturing physical, mental, and social aspects of quality of life using Likert scales (1-5 point scale: poor/never=1 to excellent/always=5). Higher score indicates more positive perceptions of overall health. | 24 weeks | 
| Sense of Belonging in Fitness Program Score | The Anderson-Butcher and Conroy Sense of Belonging survey is a 5-item questionnaire measuring sense of belonging experienced by children participating in a Fitness Program using Likert scale (1-4 point scale: NO!=1, no=2, yes=3, and YES!=4). Total Score Range 5-20: A higher score indicates a greater sense of belonging. | 24 weeks | 
| Self Esteem Score | The Rosenberg Self-Esteem survey is a 10-item questionnaire measuring self-esteem of children participating in a Fitness Program using Likert scale (0-3 point scale: Strongly disagree=0 to Strongly agree=3). Total Score Range 0-30: Higher scores indicate greater self-esteem. | 24 weeks | 
| Physical Activity Score | The Patient Reported Outcomes Measurement Information Systems (PROMIS) is a short form 4-question survey (Score 4-20) assessing physical activity over the past seven days using Likert scales (1-5 point scale: No days=1, 1 day=2, 2-3 days=3, 4-5 days=4, and 6-7 days=5). Higher score indicates higher levels of physical activity. | 24 weeks | 
| Cardio-capacity | Distance (m) on treadmill at 65% of max heart rate. | 24 weeks | 
| Heart Rate | Resting and recovery heart rate (BPM) measured before and after treadmill test. | 24 weeks | 
| Blood Pressure | Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test. | 24 weeks | 
| Waist Circumference | Waist circumference will be measured (cm) | 24 weeks | 
| Perceived Athletic Competence Score | The Harter Self-Perception Profile for Children is a short form 6-question survey (score 1-4) assessing athletic competence using a two-choice format with option then of checking Sort of True for Me or Really True for Me (A score of 1 indicates lowest and a score of 4 highest level of perceived athletic competence). | 24 weeks |