Foundations of Fitness Program Pilot

NCT ID: NCT03622086

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-06-12

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Foundations of Fitness Program

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Foundations of Fitness Program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Auden McClure

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Auden C McClure, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D18143

Identifier Type: -

Identifier Source: org_study_id