Pilot Test of Five Weight Neutral Interventions to Improve Health Among Adults of Higher Body Weight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Miriam Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Mediterranean eating style
BehavioralThe 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
BehavioralBased 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
BehavioralBased 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
BehavioralAn 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
BehavioralParticipants 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.
Treatment groups
50 Participants
are divided into 5 treatment groupsGroup A: Core ComponentExperimental treatment 2 interventions
Group B: Core Component+Mindful eating+Enjoyable exerciseExperimental treatment 4 interventions
Group C: All component conditionExperimental treatment 5 interventions
Group D: Core Component+Mindful eating+Body AppreciationExperimental treatment 4 interventions
Group E: Core component+body appreciation+enjoyment of exerciseExperimental treatment 4 interventions
Trial outcomes
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.
Time frame
End of treatment, 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Miriam Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov