Recruiting

Healthy Eating & Activity

Sponsor:

The Miriam Hospital

Code:

NCT07363616

Conditions

Obesity & Overweight

Cardiometabolic Risk Factors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mediterranean eating style

Physical activity

Mindful Eating

Body Appreciation

Enjoyable Exercise

Study Details

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

Study ID

NCT07363616

Start date

Dec 31, 2025

Status verified date

Jan, 2026

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Core Component

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

experimental: Core Component+Mindful eating+Enjoyable exercise

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.

experimental: All component condition

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.

experimental: Core Component+Mindful eating+Body Appreciation

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.

experimental: Core component+body appreciation+enjoyment of exercise

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.

Interventions

Mediterranean eating style

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

Physical activity

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.

Mindful Eating

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.

Body Appreciation

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.

Enjoyable Exercise

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.

Primary outcome measure

  • Client Satisfaction Questionnaire [ Time Frame: End of treatment, 12 weeks ]

Central Contacts and Locations

Central contacts

KayLoni Olson, PhD

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

Locations

Weight Control and Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

KayLoni Olson, PhD

401-793-8971NEW_PATH@Brownhealth.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2026-01-23.