A Culinary-Based Intensive Lifestyle Program for Patients With Obesity

NCT04624620 | Completed

• 1 other identifier: D20143
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Program Feasibility based on program attendance

  Number of classes Participants attend

  16 weeks

• Program Feasibility based on Completion rate

  Calculated using the following formula: (# completing all classes / # enrolled).

  16 weeks

• Program Feasibility based on Assessment Completion rate

  Calculated using the following formula: (# completing all assessments / # enrolled).

  16 Weeks

• Program Feasibility based on Enrollment rate

  Calculated using the following formula: \[# enrolled / (# referred \& eligible)\].

  16 weeks

• Program Feasibility based on Number of withdrawals (dropouts)

  Number of enrolled participants officially withdrawing from the study and reason for withdrawal

  16 Weeks

• Program Feasibility based on Number lost to follow up (attrition)

  Number who failed to attend sessions and could not be contacted for follow-up

  16 Weeks

• Program Acceptability based on participant interviews evaluating the pilot and assessing strengths/weaknesses.

  Program acceptability will be assessed through participant semi-structured participant interviews assessing program strengths/weaknesses.

  16 weeks

• Program Acceptability based on participant surveys

  Program acceptability will be assessed through participant surveys assessing program strengths/weaknesses. Based on \[1-5\] likert scale.

  16 weeks

Secondary Outcomes (22)

• Change in Body Weight

  Baseline, 16 weeks, 1 year

• Change in Body Mass Index

  Baseline, 16 weeks, 1 year

• Change in Waist Circumference

  Baseline, 16 weeks

• Change in Percent Body Fat

  Baseline, 16 weeks

• Change in Visceral fat area

  Baseline, 16 weeks

Other Outcomes (1)

• Staff Adoption

  16 weeks

Study Arms (1)

Pilot

EXPERIMENTAL

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.

Behavioral: Teaching Kitchen Collaborative Curriculum

Interventions

Teaching Kitchen Collaborative Curriculum 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.

Pilot

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatrics

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: January 11, 2022
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)