Pilot Trial of the Move Healthier Group
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Elizabeth Lampe, PhD
- Phone Number: 67107 (603) 646-7107
- Email: elizabeth.w.lampe@hitchcock.org
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth-Hitchcock Clinics
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Seen for weight loss treatment at DHMC Weight Center within the past year
- Speak, read, & write English fluently
- Age 18 or older
- Appropriate for group visits (as assessed by referring provider)
Exclusion Criteria:
- Meets DSM-5 criteria for an eating disorder based on behavior frequencies reported on baseline EDE-Q
- Report contraindications for unsupervised physical activity on the PAR-Q, or have not been medically cleared by an MD for participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Move Healthier Group Intervention Arm
This group-based intervention aims to promote healthy exercise without increasing risk for compensatory exercise or other disordered eating behaviors.
Participants will attend 8 weekly 90-minute group intervention sessions via telehealth software.
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The intervention aims to increase exercise using cognitive and behavioral skills integrated across several treatment manuals including the Physical Activity Cognitively Enhanced (PACE) intervention for healthy exercise promotion in eating disorders, acceptance-based and standard behavioral weight loss manuals, and affect-guided exercise prescriptions.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Objective physical activity
Time Frame: From enrollment to the end of treatment at 12 weeks
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Objective physical activity will be measures as the total number of minutes per week of physical activity measured via Fitbit device worn during waking hours.
The Fitbit data will yield a total count of the number of minutes of moderate-to-vigorous physical activity for each week during the intervention period, with higher counts indicating greater levels of activity.
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From enrollment to the end of treatment at 12 weeks
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Self-reported physical activity
Time Frame: From enrollment to the end of treatment at 12 weeks
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Participants will also complete self-report measures of physical activity, including the International Physical Activity Questionnaire (IPAQ) and IPAQ-short form at group sessions and study assessments.
The IPAQ asks patients to report on their total physical activity engagement over the past 7 days by light, moderate, and vigorous activity categories.
The IPAQ yields a total count of the number of minutes of moderate-to-vigorous physical activity over the past week, with higher minutes indicating more activity.
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From enrollment to the end of treatment at 12 weeks
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Eating disorder symptoms
Time Frame: Baseline and post-intervention (week 12)
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ED symptoms will be assessed via the Eating Disorder Examination Questionnaire (EDE-Q 6.0), which asks about ED symptoms over the past month (28 days).
Compensatory exercise engagement will be assessed via an item asking, "Over the past 28 days, how many times have you exercised to "make up for" a binge-eating episode, and compulsive exercise will be assessed using the item "...how many times have you felt driven/compelled to exercise?"
EDE-Q items are averages to calculate a total score ranging from 0-6, with higher scores indicating higher levels of eating pathology.
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Baseline and post-intervention (week 12)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight bias internalization
Time Frame: baseline and post-intervention (week 12)
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Internalized weight stigma will be measured using the Weight Bias Internalization Scale (WBIS).
The WBIS comprises 11 items measuring self-directed weight bias and has shown excellent convergent and divergent validity within the population of interest.
The WBIS items are averaged to yield a total score ranging from 1-7, with higher scores reflecting higher internalized weight bias.
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baseline and post-intervention (week 12)
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intervention acceptability
Time Frame: post-intervention (week 12)
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Participants will complete qualitative interviews at post-treatment to provide feedback on group format, acceptability, utility, etc. Qualitative analysis of these interview transcripts will elucidate themes related to group acceptability.
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post-intervention (week 12)
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intervention feasibility
Time Frame: post-intervention (week 12)
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Feasibility will be measured via group attendance rates across the 12 sessions.
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post-intervention (week 12)
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Jessica Salwen-Deremer, PhD, Dartmouth Health
- Principal Investigator: Elizabeth Lampe, PhD, Dartmouth Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STUDY02003218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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