[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530507":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":61,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":60,"enrollmentInfo":74,"targetDuration":60,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":45,"whyStopped":60,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Western University, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Choice","ACTIVE_COMPARATOR","Participants will be given a choice of 3 strategies; Group A - they receive both nutrition and exercise components simultaneously, Group B - they receive the nutrition component first followed by introduction of the exercise component sequentially, or Group C - they receive the exercise component first followed by introduction of the nutrition component sequentially.",[13],"Behavioral: Nutrition and Exercise Lifestyle Intervention Program",{"label":15,"type":16,"description":17,"interventionNames":18},"No choice","EXPERIMENTAL","Participants will be yoked (matched) to a participant in the Choice group and they receive the same strategy as the person with a choice.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Nutrition and Exercise Lifestyle Intervention Program","Nutrition and Exercise components for pregnancy",[9,15],[26],"NELIP",[28],{"name":29,"affiliation":30,"role":31},"Michelle F Mottola, PhD","Western University","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","519-661-2111","85480","mmottola@uwo.ca",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Edit Somogyi, PhD","88366","esomogyi@uwo.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario","RECRUITING","London","Ontario","N6A 3K7","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-81.23304,42.98339,{"lat":55,"lon":54},[58,59],{"name":29,"role":34,"phone":35,"phoneExt":40,"email":37},{"name":29,"role":31,"phone":60,"phoneExt":60,"email":60},null,{"type":31,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Michelle Mottola","Principal Investigator","100530507","a-nutrition-and-exercise-lifestyle-intervention-program-participant-choice-approach-100530507",false,"NCT06187675","A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach","A Participant Choice Approach to Improve Adherence and Investigate Pregnancy Outcomes to Lifestyle Interventions","Inclusion Criteria:\n\n* between 12 to 18 weeks of pregnancy\n* a singleton fetus\n* medically screened with the Get Active Questionnaire for Pregnancy to determine eligibility for participation in the exercise component\n\nExclusion Criteria:\n\n* inability to walk\n* serious medical problems\n* high blood pressure\n* uncontrolled chest pain\n* uncontrolled symptomatic lung disease\n* diabetes before pregnancy\n* a history of recreational substance use disorder\n* any contraindication to exercise\n* enrolled in another clinical trial.",true,"FEMALE","18 Years",{"count":75,"type":76},120,"ESTIMATED","INTERVENTIONAL",[79],"NA","Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle Intervention Program (NELIP) and found that those individuals with high adherence to the program were more likely to prevent EGWG. Perhaps offering participants a choice to intervention strategies may improve adherence. The current research question is: What impact does participant choice have on adherence to the introduction of nutrition and exercise components during 3 intervention strategies offered to pregnant individuals compared to no choice and does choice maintain pregnancy health outcomes? The strategies are: Group A - introducing both the nutrition and exercise components simultaneous at baseline (12-18 weeks of pregnancy) that is followed to delivery (NELIP); Group B - introducing the nutrition component first and then at 25 weeks adding the exercise component; or Group C - starting with the exercise component first, followed with introducing the nutrition component at 25 weeks. Both Groups B and C follow the full NELIP from 25 weeks to delivery (final intervention measures will occur at 34-36 weeks gestation). Follow-up will occur at birth (6-18 hours), 2, 6 and 12 months post delivery.",[82,83,84,85,86],"Lifestyle, Healthy","Pregnancy Related","Adherence, Treatment","Nutrition, Healthy","Weight Gain, Maternal",[88,89,90,91,92],"pregnancy","lifestyle","nutrition","exercise","adherence","2024-03-01",{"date":95,"type":96},"2024-03-05","ACTUAL",{"date":98,"type":96},"2024-01-01",{"date":100,"type":76},"2029-11",{"name":5,"class":6},1]