Pilot Test of Five Weight Neutral Interventions to Improve Health Among Adults of Higher Body Weight

NCT07363616 | Recruiting

• 1 other identifier: R03DK140291
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight; Cardiometabolic Risk Factors

Keywords

Mediterannean diet; Physical Activity; Weight Neutral; Lifestyle intervention; Mindful eating; Mindfulness-based Eating Awareness Training; Body Image; Obesity; Overweight; Cardiometabolic health; Multiphase Optimization STrategy (MOST); MOST Preparation Phase; Body appreciation

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire

  This 8-item self-report measure captures perceived quality and usefulness and overall satisfaction with treatment. Scores range from 8-32 with higher scores reflecting a more positive view of treatment.

  End of treatment, 12 weeks

Study Arms (5)

Core Component

EXPERIMENTAL

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

Behavioral: Mediterranean eating style; Behavioral: Physical activity

Core Component+Mindful eating+Enjoyable exercise

EXPERIMENTAL

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.

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

All component condition

EXPERIMENTAL

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.

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

Core Component+Mindful eating+Body Appreciation

EXPERIMENTAL

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.

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

Core component+body appreciation+enjoyment of exercise

EXPERIMENTAL

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.

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

Interventions

Mediterranean eating style BEHAVIORAL

The Mediterranean eating style is characterized by high intake of minimally processed, plant-based foods (fruits, vegetables, whole grains, beans and nuts), high intake of olive oil, moderate intake of dairy, low intake of red meat, and wine in moderation. This dietary pattern emphasizes inclusion of health promoting foods rather than focusing on restricting types and quantities of food, weight change is not a goal of this approach, and it is flexible rather than rule based to accommodate tastes/preferences. Daily self monitoring is a key strategy to support adherence to this eating style

All component condition; Core Component; Core Component+Mindful eating+Body Appreciation; Core Component+Mindful eating+Enjoyable exercise; Core component+body appreciation+enjoyment of exercise

Physical activity BEHAVIORAL

Based on the Physical Activity Guidelines for Americans (PAG) which provide a evidence-based summary of key recommendations for adults in the United States to achieve the robust health benefits accessible through regular physical activity. Recommendations include 150 minutes of moderate-to-vigorous aerobic exercise per week, muscle strengthening activities 2 times per week, and reducing daily sedentary time. Participants will receive psychoeducation and explore examples of activities that will help achieve the goal. Strategies for monitoring exercise will be reviewed.

All component condition; Core Component; Core Component+Mindful eating+Body Appreciation; Core Component+Mindful eating+Enjoyable exercise; Core component+body appreciation+enjoyment of exercise

Mindful Eating BEHAVIORAL

Based on Mindfulness-Based Eating Awareness Training (MB-EAT) which is a multi-session, group-based intervention designed to increase awareness of both internal and external cues to eat and to facilitate the capacity to regulate eating behaviors and food intake in response to these cues. These skills are developed through experiential activities that are completed in the group setting during each meeting including regular mindfulness practice and mindfulness activities specifically applied to the experience of eating. Participants are also given mindfulness activities to practice between group meetings.

All component condition; Core Component+Mindful eating+Body Appreciation; Core Component+Mindful eating+Enjoyable exercise

Body Appreciation BEHAVIORAL

An adapted version of the Body Project, a dissonance-based body appreciation program designed to increase awareness of and actively challenge sociocultural factors that promote negative body image and can disrupt healthy eating and exercise. Participants engage in group discussion and experiential activities to practice resisting sources of pressure to conform to unhealthy body standards. Between-session activities help participants translate knowledge and skills to their daily lives.

All component condition; Core Component+Mindful eating+Body Appreciation; Core component+body appreciation+enjoyment of exercise

Enjoyable Exercise BEHAVIORAL

Participants will be provided with a brief overview and rationale for the importance of finding enjoyable ways to be physically active. Participants will experiment with different, evidence-based strategies to boost affect during exercise to build an activity routine that is enjoyable.

All component condition; Core Component+Mindful eating+Enjoyable exercise; Core component+body appreciation+enjoyment of exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

KayLoni Olson, PhD

CONTACT

401-793-8971; kayloni.olson@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 23, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available at the time of associated publication or the end of the project funding period, whichever comes first. The data will be retained with the repository for approximately 3 years past the publication date of the primary aims to permit sufficient time for replication of fundings.
• Access Criteria: Data will be uploaded by the PI into a repository that will meet compliance for federally funded research. The PI has authority to grant or limit access to the data. Upon receipt of request for access, the PI and investigative team will review to determine if the proposed use is scientifically justified and appropriate. If so, access to data will be granted through the portal, in coordination with the PI's institutional compliance department for data sharing, for time-limited use with potential for extension upon receipt of signed agreement to terms of use.

Locations

US (1)