Body Mass Index, Health Behavior, Pediatric Obesity, Self Esteem
Conditions
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.
Interventions
OTHERFoundations 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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cardio-capacity | 24 weeks | Distance (m) on treadmill at 65% of max heart rate. |
| Heart Rate | 24 weeks | Resting and recovery heart rate (BPM) measured before and after treadmill test. |
| Blood Pressure | 24 weeks | Resting and recovery systolic and diastolic Blood pressure (mmHg) 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). |
| 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. |
| 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). |
| 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) |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fidelity to planned program | 24 weeks | We will assess percent of planned class sessions and planned outcome assessments that were administered. |
| Staff program adoption | 24 weeks | Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program. |
Countries
United States
Outcome results
None listed