Foundations of Fitness Program Pilot
- Conditions
- Self EsteemPediatric ObesityHealth BehaviorBody Mass Index
- Interventions
- Other: Foundations of Fitness Program
- Registration Number
- NCT03622086
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Age 7-13 years;
- BMI% ≥85th%;
- Regional pediatric medical home patient;
- English speaking child and parent/caregiver;
- Physical or developmental limitation to participation as determined by referring provider
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 11-13 years old 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. 7-10 years old 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.
- Primary Outcome Measures
Name Time Method Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program. 24 weeks 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.
Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses. 24 weeks Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
Program Eligibility rate 24 weeks Calculated using the following formula: \[# screen positive / # screened for inclusion\].
Program Enrollment rate 24 weeks Calculated using the following formula: \[# enrolled / (# screen positive \& eligible)\]. We will assess reasons for dropout/non-adherence.
Program Completion rate 24 weeks Calculated using the following formula: (# completing all sessions / # enrolled).
Assessment Completion rate 24 weeks Calculated using the following formula: (# completing all assessments / # enrolled).
Participant Satisfaction Survey 24 weeks 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).
- Secondary Outcome Measures
Name Time Method Body Mass Index Percentile 48 weeks 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.
Health Habits Survey 24 weeks 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)
Strength Assessment 24 weeks 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).
Subjective Health and Quality of Life Score 24 weeks 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.
Heart Rate 24 weeks Resting and recovery heart rate (BPM) measured before and after treadmill test.
Waist Circumference 24 weeks Waist circumference will be measured (cm)
Perceived Athletic Competence Score 24 weeks 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).
Sense of Belonging in Fitness Program Score 24 weeks 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.
Self Esteem Score 24 weeks 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.
Physical Activity Score 24 weeks 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.
Cardio-capacity 24 weeks Distance (m) on treadmill at 65% of max heart rate.
Blood Pressure 24 weeks Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
Trial Locations
- Locations (1)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States