Pediatric ObesityNCT03622086
Foundations of Fitness Program Pilot
A study testing Foundations of Fitness Program in people with Pediatric Obesity and Health Behavior, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Health Behavior, Body Mass Index
- What is being tested?
- Foundations of Fitness Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 12 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7-13 years;
- BMI% ≥85th%;
- Regional pediatric medical home patient;
- English speaking child and parent/caregiver;
Who cannot join
- Physical or developmental limitation to participation as determined by referring provider
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: 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.
- Conditions
- Pediatric Obesity, Health Behavior, Body Mass Index, Self Esteem
- Being tested
- Foundations of Fitness Program
- Medical subject headings
- Pediatric Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foundations of Fitness ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Foundations of Fitness Program |
| 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. Receives: Other: Foundations of Fitness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Program Eligibility rate
Calculated using the following formula: [# screen positive / # screened for inclusion].
Measured: 24 weeks
Program Enrollment rate
Calculated using the following formula: [# enrolled / (# screen positive \& eligible)]. We will assess reasons for dropout/non-adherence.
Measured: 24 weeks
Program Completion rate
Calculated using the following formula: (# completing all sessions / # enrolled).
Measured: 24 weeks
Assessment Completion rate
Calculated using the following formula: (# completing all assessments / # enrolled).
Measured: 24 weeks
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).
Measured: 24 weeks
Secondary outcomes (12)
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.
Measured: 48 weeks
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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Cardio-capacity
Distance (m) on treadmill at 65% of max heart rate.
Measured: 24 weeks
Heart Rate
Resting and recovery heart rate (BPM) measured before and after treadmill test.
Measured: 24 weeks
Blood Pressure
Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
Measured: 24 weeks
Waist Circumference
Waist circumference will be measured (cm)
Measured: 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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start12 Jul 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Auden McClure, Dartmouth-Hitchcock Medical Center
- Investigators
- Auden C McClure, MD MPH, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622086
- Sponsor's protocol ID
- D18143
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
- ClinicalTrials.gov ID
- NCT03622086
- Acronym / sponsor ID
- D18143
- Conditions
- Pediatric Obesity, Health Behavior, Body Mass Index, Self Esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-10 years old | Experimental | Other: Foundations of Fitness ProgramChildren-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. |
| 11-13 years old | Experimental | Other: Foundations of Fitness ProgramChildren-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. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 7-13 years;
- BMI% ≥85th%;
- Regional pediatric medical home patient;
- English speaking child and parent/caregiver;
Key exclusion criteria (1 listed)
- Physical or developmental limitation to participation as determined by referring provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foundations of Fitness ProgramThe 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. | Other | 11-13 years old, 7-10 years old |
Primary outcome
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.
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.
Program Eligibility rate
Time frame: 24 weeks
Calculated using the following formula: [# screen positive / # screened for inclusion].
Program Enrollment rate
Time frame: 24 weeks
Calculated using the following formula: [# enrolled / (# screen positive \& eligible)]. We will assess reasons for dropout/non-adherence.
Program Completion rate
Time frame: 24 weeks
Calculated using the following formula: (# completing all sessions / # enrolled).
Assessment Completion rate
Time frame: 24 weeks
Calculated using the following formula: (# completing all assessments / # enrolled).
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).
12 secondary outcomes
Body Mass Index Percentile
Time frame: 48 weeks
Strength Assessment
Time frame: 24 weeks
Health Habits Survey
Time frame: 24 weeks
Subjective Health and Quality of Life Score
Time frame: 24 weeks
Sense of Belonging in Fitness Program Score
Time frame: 24 weeks
Self Esteem Score
Time frame: 24 weeks
Physical Activity Score
Time frame: 24 weeks
Cardio-capacity
Time frame: 24 weeks
Heart Rate
Time frame: 24 weeks
Blood Pressure
Time frame: 24 weeks
Waist Circumference
Time frame: 24 weeks
Perceived Athletic Competence Score
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Auden C McClure, MD MPH principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foundations of Fitness Program in people with Pediatric Obesity and Health Behavior, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.