- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622086
Foundations of Fitness Program Pilot
July 8, 2019 updated by: Auden McClure, Dartmouth-Hitchcock Medical Center
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 7-10 years old
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.
|
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.
|
Experimental: 11-13 years old
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.
|
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.
|
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.
Time Frame: 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.
|
24 weeks
|
Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
Calculated using the following formula: [# screen positive / # screened for inclusion].
|
24 weeks
|
Program Enrollment rate
Time Frame: 24 weeks
|
Calculated using the following formula: [# enrolled / (# screen positive & eligible)].
We will assess reasons for dropout/non-adherence.
|
24 weeks
|
Program Completion rate
Time Frame: 24 weeks
|
Calculated using the following formula: (# completing all sessions / # enrolled).
|
24 weeks
|
Assessment Completion rate
Time Frame: 24 weeks
|
Calculated using the following formula: (# completing all assessments / # enrolled).
|
24 weeks
|
Participant Satisfaction Survey
Time Frame: 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).
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index Percentile
Time Frame: 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.
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48 weeks
|
Strength Assessment
Time Frame: 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
Time Frame: 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)
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24 weeks
|
Subjective Health and Quality of Life Score
Time Frame: 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.
|
24 weeks
|
Sense of Belonging in Fitness Program Score
Time Frame: 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.
|
24 weeks
|
Self Esteem Score
Time Frame: 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.
|
24 weeks
|
Physical Activity Score
Time Frame: 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.
|
24 weeks
|
Cardio-capacity
Time Frame: 24 weeks
|
Distance (m) on treadmill at 65% of max heart rate.
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24 weeks
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Heart Rate
Time Frame: 24 weeks
|
Resting and recovery heart rate (BPM) measured before and after treadmill test.
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24 weeks
|
Blood Pressure
Time Frame: 24 weeks
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Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
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24 weeks
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Waist Circumference
Time Frame: 24 weeks
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Waist circumference will be measured (cm)
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24 weeks
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Perceived Athletic Competence Score
Time Frame: 24 weeks
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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).
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24 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Staff program adoption
Time Frame: 24 weeks
|
Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program.
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24 weeks
|
Fidelity to planned program
Time Frame: 24 weeks
|
We will assess percent of planned class sessions and planned outcome assessments that were administered.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Auden C McClure, MD MPH, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2018
Primary Completion (Actual)
June 12, 2019
Study Completion (Actual)
June 12, 2019
Study Registration Dates
First Submitted
July 18, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (Actual)
August 9, 2018
Study Record Updates
Last Update Posted (Actual)
July 10, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D18143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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