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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7-10 years old | Experimental | 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. |
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| 11-13 years old | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foundations of Fitness Program | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Staff program adoption | Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program. | 24 weeks |
| Fidelity to planned program |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Auden C McClure, MD MPH | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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 |
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 |
We will assess percent of planned class sessions and planned outcome assessments that were administered.
| 24 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |