A Culinary-Based Intensive Lifestyle Program for Patients With Obesity

NCT ID: NCT04624620

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2022-05-13

Brief Summary

The study team proposes in this pilot to test, in a single-arm mixed-methods study, the feasibility, acceptability, and preliminary effectiveness of the 16 modular classes taught by a chef, dietitian, and health coach. While the pilot may not have the power to detect significant change, it will provide preliminary data for a NIH application to further test this curriculum in a pragmatic, community-based, randomized multi-site Teaching Kitchen Collaborative Curriculum (TKCC) study planned for Jan 2022 or thereafter. If effective, the TKCC has potential to impact population health through translation into teaching kitchens nationally and adaptation to clinic /community settings.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilot

Participants will participate in a 16 week, culinary intensive study that will consist of 2 hour virtual classes taught by a chef, a dietitian, and a health coach that focus on diet, culinary competency, daily physical activity, mindfulness and support for behavior change.

Group Type: EXPERIMENTAL

Teaching Kitchen Collaborative Curriculum

Intervention Type: BEHAVIORAL

This is a referral-based teaching kitchen intervention that synergistically provides basic cooking skills, an evidence-based nutrition curriculum, mindfulness skills, activity tracking, and support for behavior change to augment weight management and lifestyle change in the primary care setting.

Interventions

Teaching Kitchen Collaborative Curriculum

This is a referral-based teaching kitchen intervention that synergistically provides basic cooking skills, an evidence-based nutrition curriculum, mindfulness skills, activity tracking, and support for behavior change to augment weight management and lifestyle change in the primary care setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Community-dwelling
• English speaking patients
• Aged 30-65 (in order to capture adults living independently)
• Diagnosis of class I or II obesity (BMI 30-39.9 kg/m2)
• Participants must be available for and willing to commit to the sixteen classes either in person or virtually.
• Must have a device with a camera (smartphone, tablet, computer)
• Use email and text
• Home Wi-Fi with high-speed internet
• Must have minimal cooktop and oven capacity at home
• Participants will be referred AND have medical clearance from a primary care provider at Dartmouth-Hitchcock

Exclusion Criteria

• Patients taking obesity or diabetes medications as assessed by study medical director
• severe obesity (BMI≥40kg/m2)
• Diagnosis of Type 2 diabetes (HA1C ≥ 6.5) in the past (excluding gestational diabetes)
• implanted electronic medical device
• History of bariatric surgery
• Current participation in a longitudinal culinary or weight management program, including the D-H Weight and Wellness Center
• Severe mental health or life-threatening illnesses
• Unstable cardiovascular disease
• Hospitalization for depression in past 6 month
• Self-report of alcohol or substance abuse within the past 12 months
• Diet / exercise contraindications
• Other medical, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocols determined by PI
• Prisoners
• Pregnant women will not be eligible to participate nor will those unable or unwilling to give informed consent or communicate with local study staff.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Auden McClure

Assistant Professor in Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D20143

Identifier Type: -

Identifier Source: org_study_id