Foundations of Fitness Program Pilot

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622086
• Other study ID #: D18143
• Status: Completed
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: June 12, 2019

Study information

• Verified date: July 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 12, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Mass Index
• Health Behavior
• Obesity
• Pediatric Obesity
• Self Esteem

Intervention

Other:
• Foundations 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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Fidelity to planned program	We will assess percent of planned class sessions and planned outcome assessments that were administered.	24 weeks
Primary	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
Primary	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
Primary	Program Eligibility rate	Calculated using the following formula: [# screen positive / # screened for inclusion].	24 weeks
Primary	Program Enrollment rate	Calculated using the following formula: [# enrolled / (# screen positive & eligible)]. We will assess reasons for dropout/non-adherence.	24 weeks
Primary	Program Completion rate	Calculated using the following formula: (# completing all sessions / # enrolled).	24 weeks
Primary	Assessment Completion rate	Calculated using the following formula: (# completing all assessments / # enrolled).	24 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cardio-capacity	Distance (m) on treadmill at 65% of max heart rate.	24 weeks
Secondary	Heart Rate	Resting and recovery heart rate (BPM) measured before and after treadmill test.	24 weeks
Secondary	Blood Pressure	Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.	24 weeks
Secondary	Waist Circumference	Waist circumference will be measured (cm)	24 weeks
Secondary	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