Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 3:23 AM
Study NCT ID:
NCT04919759
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2021-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034752', 'term': 'Basic Blue K'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arms, non-randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '16 weeks', 'description': 'changes in body weight'}, {'measure': 'Body composition', 'timeFrame': '16 weeks', 'description': 'Changes in body composition (percent body fat)'}], 'secondaryOutcomes': [{'measure': 'Nutrition knowledge', 'timeFrame': '16 weeks', 'description': 'The General Nutrition Awareness Questionnaire (GNKQ) validated by Parmenter and Wardle in the UK. was used after local adaptation. Four main categories containing a total of 58 items were assessed:1) Awareness of dietary recommendations (11 items); 2) Knowledge of sources of nutrients (37 items); (3) Using the information to make dietary choices (5 items); and 4) Awareness of diet-disease relationships (5 items).'}, {'measure': 'Physical activity', 'timeFrame': '16 weeks', 'description': 'Changes in physical activity (number of days and duration) was used using The International Physical Activity Questionnaire (IPAQ) - Short Form'}, {'measure': 'Perceived social support from family and closest friends.', 'timeFrame': '16 weeks', 'description': 'Perceived social support for healthier foods and physical activity scale of Health Beliefs Questionnaire which was originally developed by Anderson, E. and colleagues was used after adaptation for university students in the UAE. The social support subscale (16 items for healthy eating and 7 items for physical activity) measures social influences on participants by their family members and closest friends. Each question is scored 1-5 (1 - Strongly disagree, 5 - Strongly agree).'}, {'measure': 'Perceived self-efficacy for healthier eating and physical activity', 'timeFrame': '16 weeks', 'description': "Perceived self-efficacy scale of Health Beliefs Questionnaire which was originally developed by Anderson, E. and colleagues after local adaptation was used. It consists of 33 items for healthy eating and 24 items for physical activity. The healthy food efficacy measure assesses the respondent's confidence in reducing fat, reducing sugar consumption and increasing fruit and vegetable intake. The physical activity measure consists of two subscales: overcoming barriers to engaging in physical activity and integrating physical activity into the daily routine. Each question is scored 0 to 100 (certain I cannot) to 100) all or most of the time."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. The intervention was implemented in two universities in the United Arab Emirates', 'detailedDescription': 'Poor eating habits and sedentary lifestyle are common among young adults and increase risk for chronic diseases in subsequent years of life. Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. The study intervention was guided by Social Cognitive Theory. The study involved the development of a website, integrating educational material and mobile applications for monitoring diet and physical activity and a16-week feasibility trial to promote weight loss, improve food choices and increase physical activity levels. The trial consisted of two arms: Rashakaty Basic (R-Basic) and Rashakaty Enhanced (R-Enhanced).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight or obese (BMI ≥25.0\n* Adults: Female\n* Age: 18-35 years\n* Current user of a smart phone\n* Student in one of the two target universities in the United Arab Emirates\n* Living in or off the university campus\n\nExclusion Criteria:\n\n* Past or planned weight loss surgery\n* Pregnant or breastfeeding\n* Lost 7 kg in the past 3 months\n* Following any weight loss program for 3 months or more\n* Taking any steroid or thyroid hormones treatment or any other medication that may affect body weight\n* Enrolled in medical and nutrition programs since one of the program components was nutrition knowledge assessments'}, 'identificationModule': {'nctId': 'NCT04919759', 'acronym': 'Rashakaty', 'briefTitle': 'Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'United Arab Emirates University'}, 'officialTitle': 'Development, Implementation and Evaluation of Technology Mediated Lifestyle Intervention for Promoting Weight Loss and Improving Nutrition Behaviors Among Young Adults', 'orgStudyIdInfo': {'id': '33/2014/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rashakaty Basic (R-Basic)', 'description': 'Participants in the R-Basic intervention arm had access to a website that contained the study questionnaires and nutrition education materials', 'interventionNames': ['Behavioral: R-Basic']}, {'type': 'EXPERIMENTAL', 'label': 'Rashakaty Enhanced (R-Enhanced)', 'description': 'Participants in the R-Enhanced intervention were given access to smart phones applications for monitoring diet and physical activity levels as well as an online access to a nutritionist', 'interventionNames': ['Behavioral: R-Enhanced']}], 'interventions': [{'name': 'R-Basic', 'type': 'BEHAVIORAL', 'otherNames': ['Rashakaty Basic intervention'], 'description': 'Participants in the R-Basic arm received access to a static website that contained educational materials on healthier eating and physical activity and the study questionnaires. The R-Basic intervention was implemented in the University of Sharjah.', 'armGroupLabels': ['Rashakaty Basic (R-Basic)']}, {'name': 'R-Enhanced', 'type': 'BEHAVIORAL', 'otherNames': ['Rashakaty Enhanced intervention'], 'description': 'The R-Enhanced intervention was guided by the Social Cognitive Theory and employed a variety of behavior modification strategies, including self-monitoring, goal setting, self-efficacy, and social support to facilitate changes in diet and physical activity. In addition, participants in the R-Enhanced intervention had online access to a nutritionist. The R-Enhanced intervention was implemented in the United Arab Emirates University.', 'armGroupLabels': ['Rashakaty Enhanced (R-Enhanced)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Ain City', 'state': 'Select State Or Region', 'country': 'United Arab Emirates', 'facility': 'United Arab Emirates University', 'geoPoint': {'lat': 24.19167, 'lon': 55.76056}}], 'overallOfficials': [{'name': 'Habiba I Ali, PhD, RD, CDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United Arab Emirates University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Arab Emirates University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sharjah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Habiba I. Ali', 'investigatorAffiliation': 'United Arab Emirates University'}}}}