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Foundations of Fitness Program Pilot

Primary Purpose

Pediatric Obesity, Health Behavior, Body Mass Index

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foundations of Fitness Program
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

7 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

7-10 years old

11-13 years old

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Program Eligibility rate
Calculated using the following formula: [# screen positive / # screened for inclusion].
Program Enrollment rate
Calculated using the following formula: [# enrolled / (# screen positive & eligible)]. We will assess reasons for dropout/non-adherence.
Program Completion rate
Calculated using the following formula: (# completing all sessions / # enrolled).
Assessment Completion rate
Calculated using the following formula: (# completing all assessments / # enrolled).
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).

Secondary Outcome Measures

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.
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).
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)
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.
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.
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.
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.
Cardio-capacity
Distance (m) on treadmill at 65% of max heart rate.
Heart Rate
Resting and recovery heart rate (BPM) measured before and after treadmill test.
Blood Pressure
Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
Waist Circumference
Waist circumference will be measured (cm)
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).

Full Information

First Posted
July 18, 2018
Last Updated
July 8, 2019
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03622086
Brief Title
Foundations of Fitness Program Pilot
Official Title
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Health Behavior, Body Mass Index, Self Esteem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7-10 years old
Arm Type
Experimental
Arm Description
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.
Arm Title
11-13 years old
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Foundations of Fitness Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
Description
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.
Time Frame
24 weeks
Title
Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
Description
Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
Time Frame
24 weeks
Title
Program Eligibility rate
Description
Calculated using the following formula: [# screen positive / # screened for inclusion].
Time Frame
24 weeks
Title
Program Enrollment rate
Description
Calculated using the following formula: [# enrolled / (# screen positive & eligible)]. We will assess reasons for dropout/non-adherence.
Time Frame
24 weeks
Title
Program Completion rate
Description
Calculated using the following formula: (# completing all sessions / # enrolled).
Time Frame
24 weeks
Title
Assessment Completion rate
Description
Calculated using the following formula: (# completing all assessments / # enrolled).
Time Frame
24 weeks
Title
Participant Satisfaction Survey
Description
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).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Body Mass Index Percentile
Description
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.
Time Frame
48 weeks
Title
Strength Assessment
Description
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).
Time Frame
24 weeks
Title
Health Habits Survey
Description
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)
Time Frame
24 weeks
Title
Subjective Health and Quality of Life Score
Description
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.
Time Frame
24 weeks
Title
Sense of Belonging in Fitness Program Score
Description
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.
Time Frame
24 weeks
Title
Self Esteem Score
Description
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.
Time Frame
24 weeks
Title
Physical Activity Score
Description
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.
Time Frame
24 weeks
Title
Cardio-capacity
Description
Distance (m) on treadmill at 65% of max heart rate.
Time Frame
24 weeks
Title
Heart Rate
Description
Resting and recovery heart rate (BPM) measured before and after treadmill test.
Time Frame
24 weeks
Title
Blood Pressure
Description
Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
Time Frame
24 weeks
Title
Waist Circumference
Description
Waist circumference will be measured (cm)
Time Frame
24 weeks
Title
Perceived Athletic Competence Score
Description
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).
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Staff program adoption
Description
Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program.
Time Frame
24 weeks
Title
Fidelity to planned program
Description
We will assess percent of planned class sessions and planned outcome assessments that were administered.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auden C McClure, MD MPH
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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