Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:39 AM
Study NCT ID:
NCT07406568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Trial of the Move Healthier Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective physical activity', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': '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.'}, {'measure': 'Self-reported physical activity', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': '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.'}, {'measure': 'Eating disorder symptoms', 'timeFrame': 'Baseline and post-intervention (week 12)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Weight bias internalization', 'timeFrame': 'baseline and post-intervention (week 12)', 'description': '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.'}, {'measure': 'intervention acceptability', 'timeFrame': 'post-intervention (week 12)', 'description': '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.'}, {'measure': 'intervention feasibility', 'timeFrame': 'post-intervention (week 12)', 'description': 'Feasibility will be measured via group attendance rates across the 12 sessions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'physical activity', 'disordered eating', 'eating disorder'], 'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The researchers are developing a new exercise-focused group and are interested in studying whether this group helps people increase their exercise without increasing risk for disordered eating behaviors.', 'detailedDescription': 'Individuals seeking weight loss are often encouraged to increase their exercise engagement as a health-promoting behavior. However, exercise engagement is often connected directly to caloric intake within weight loss interventions, so it is likely that individuals seeking weight loss are engaging in some level of compensatory exercise even in the absence of other disordered eating symptoms. Compensatory exercise is defined as exercising to "offset" or "make up for" calories consumed with the intent of controlling one\'s body weight or shape. The researchers are developing a new group to promote healthy exercise and are interested in studying whether this group helps people increase their exercise without increasing risk for compensatory exercise or other disordered eating behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seen for weight loss treatment at DHMC Weight Center within the past year\n* Speak, read, \\& write English fluently\n* Age 18 or older\n* Appropriate for group visits (as assessed by referring provider)\n\nExclusion Criteria:\n\n* Meets DSM-5 criteria for an eating disorder based on behavior frequencies reported on baseline EDE-Q\n* Report contraindications for unsupervised physical activity on the PAR-Q, or have not been medically cleared by an MD for participation.'}, 'identificationModule': {'nctId': 'NCT07406568', 'briefTitle': 'Pilot Trial of the Move Healthier Group', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Pilot Trial of the Move Healthier Group', 'orgStudyIdInfo': {'id': 'STUDY02003218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Move Healthier Group Intervention Arm', 'description': 'This group-based intervention aims to promote healthy exercise without increasing risk for compensatory exercise or other disordered eating behaviors. Participants will attend 12 weekly 90-minute group intervention sessions via telehealth software.', 'interventionNames': ['Behavioral: Move Healthier Intervention']}], 'interventions': [{'name': 'Move Healthier Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Move Healthier Group Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Lampe, PhD', 'role': 'CONTACT', 'email': 'elizabeth.w.lampe@hitchcock.org', 'phone': '(603) 646-7107', 'phoneExt': '67107'}, {'name': 'Elizabeth Lampe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jessica Salwen-Deremer, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dartmouth-Hitchcock Clinics', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'centralContacts': [{'name': 'Elizabeth Lampe, PhD', 'role': 'CONTACT', 'email': 'elizabeth.w.lampe@hitchcock.org', 'phone': '(603) 646-7107', 'phoneExt': '67107'}], 'overallOfficials': [{'name': 'Jessica Salwen-Deremer, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dartmouth Health'}, {'name': 'Elizabeth Lampe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychology Fellow, Weight Center', 'investigatorFullName': 'Elizabeth.W.Lampe', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}