Pilot Test of Five Weight Neutral Interventions to Improve Health Among Adults of Higher Body Weight (NEW PATH)

Lifespan

Status: Enrolling

Conditions: Cardiometabolic Risk Factors; Obesity & Overweight

Treatments: Behavioral: Physical activity; Behavioral: Mindful Eating; Behavioral: Body Appreciation; Behavioral: Enjoyable Exercise; Behavioral: Mediterranean eating style

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07363616

R03DK140291 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to pilot test five different, group based and remotely delivered programs designed to support healthy eating and regular physical activity. Each group will contain information and support for healthy eating and physical activity. Groups may also include support to 1) eat with more awareness of hunger and fullness, 2) improve how people think and feel about their bodies, and/or 3) identify ways to be physically active that are more enjoyable. Each group will include a unique combination of these components and the goal is to assess overall satisfaction and engagement with each of the programs.

Full description

The goal of study is to conduct a Multiphase Optimization STrategy (MOST) Preparation phase study to combine and pilot test candidate components for a group-based, remotely delivered weight neutral/healthy lifestyle intervention. Potential treatment components will include the following existing, evidence-based interventions; (1) mindfulness-based eating awareness training , (2) body acceptance program , and (3) a tailored intervention to promote enjoyment of physical activity. Weight neutral components will complement a Core intervention of standardized education on healthy diet (emphasizing the Mediterranean diet) and Physical Activity Guidelines for Americans (i.e., aerobic activity, muscle strengthening). This phase of the science is focused on pilot testing to ensure the target sample can be recruited and and that the novel combinations of treatment components can be delivered as intended. To make strategic use of resources, a fractional factorial design will be used to pilot test five conditions: the Core intervention alone and all possible combinations of the Core intervention + two or more of the weight neutral components. Men and women (n=50) with BMI≥25kg/m2 will be recruited and randomized in small groups (n=10) to receive one of the five conditions held online (each 12 weeks in duration).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years and older
• BMI between 25-40 (if BMI is between 25-30 then additional cardiometabolic risk factor must be present including hypertension, high cholesterol, prediabetes or type 2 diabetes)

Exclusion criteria

• current participation in a formal weight loss program
• current use of weight loss medication
• history of bariatric surgery
• physical condition that would limit the ability to engage in moderate intensity physical activity
• current pregnancy
• recent weight loss of 5% body weight
• condition that may interfere with ability to complete the study procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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50 participants in 5 patient groups

Core Component

Experimental group

Description:

Participants in the Core component condition will receive guidance and support for healthy eating and regular physical activity.

Treatment:

Behavioral: Mediterranean eating style

Behavioral: Physical activity

Core Component+Mindful eating+Enjoyable exercise

Experimental group

Description:

Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and to explore/identify ways to enjoy physical activity.

Treatment:

Behavioral: Mediterranean eating style

Behavioral: Enjoyable Exercise

Behavioral: Mindful Eating

Behavioral: Physical activity

All component condition

Experimental group

Description:

Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.

Treatment:

Behavioral: Mediterranean eating style

Behavioral: Enjoyable Exercise

Behavioral: Body Appreciation

Behavioral: Mindful Eating

Behavioral: Physical activity

Core Component+Mindful eating+Body Appreciation

Experimental group

Description:

Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and strategies to improve how they think and feel about their bodies.

Treatment:

Behavioral: Mediterranean eating style

Behavioral: Body Appreciation

Behavioral: Mindful Eating

Behavioral: Physical activity

Core component+body appreciation+enjoyment of exercise

Experimental group

Description:

Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.

Treatment:

Behavioral: Mediterranean eating style

Behavioral: Enjoyable Exercise

Behavioral: Body Appreciation

Behavioral: Physical activity