Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT01949558
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2013-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care
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': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2013-09-20', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reported dietary intake', 'timeFrame': '1 and 2 yrs post intervention start', 'description': 'Reported dietary intake by 24 hr recall'}, {'measure': 'Physical activity', 'timeFrame': '1 yr after start of intervention', 'description': 'Step counter worn during 5 days'}, {'measure': 'Quality of Life as measured by two validated scales', 'timeFrame': '1 and 2 yrs after intervention start', 'description': 'Participants fill in EQ-5D, which is a validated scale often used to calculate QoL'}, {'measure': 'TLC, Transformative Lifestyle Change', 'timeFrame': 'At start and end of intervention', 'description': 'Questions on TLC'}, {'measure': 'Quality of Life as measured by SF-36', 'timeFrame': '1 and 2 years after intervention start', 'description': 'participants fill in SF-36, which is a validated scale, to calculate QoL'}], 'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': '1 and 2 yrs post intervention start'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': '1 and 2 years post intervention start'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diet', 'lifestyle'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '30621673', 'type': 'DERIVED', 'citation': 'Hagberg L, Winkvist A, Brekke HK, Bertz F, Hellebo Johansson E, Huseinovic E. Cost-effectiveness and quality of life of a diet intervention postpartum: 2-year results from a randomized controlled trial. BMC Public Health. 2019 Jan 8;19(1):38. doi: 10.1186/s12889-018-6356-y.'}, {'pmid': '27413127', 'type': 'DERIVED', 'citation': 'Huseinovic E, Bertz F, Leu Agelii M, Hellebo Johansson E, Winkvist A, Brekke HK. Effectiveness of a weight loss intervention in postpartum women: results from a randomized controlled trial in primary health care. Am J Clin Nutr. 2016 Aug;104(2):362-70. doi: 10.3945/ajcn.116.135673. Epub 2016 Jul 13.'}]}, 'descriptionModule': {'briefSummary': "Chronic diseases such as overweight and cardiovascular diseases represent important threats to women's health. Pregnancy and lactation are associated with changes in weight, body composition and lipid metabolism and affect the risk of developing these chronic illnesses. Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese women's ability to make longterm lifestyle changes during the postpartum (pp) period, under ideal study conditions. Physiological mechanisms for weight reduction were investigated with precise methodology. However, effectiveness studies under different conditions are crucial for the development of effective programs for the Primary Health Care sector. Hence, the interest for translational research that brings results from clinical trials to the Primary Health Care sector has increased. The aim of this effectiveness-study is to investigate if dietary restrictions pp lead to significantly greater weight reduction among overweight/obese women, compared to no intervention, in a longterm perspective. In total 106 women will be recruited 10 wk pp and randomized into 1) control group; 2) dietary restrictions in individualized intervention during 12 wks. One and two years pp long term effects are evaluated. Positive results may be integrated into usual practice after the study ends."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria \\* BMI at 10 w postpartum \\>= 27.0\n\nExclusion Criteria\n\n\\*Serious disease in mother or child'}, 'identificationModule': {'nctId': 'NCT01949558', 'acronym': 'LIV', 'briefTitle': 'Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'From Efficacy to Effectiveness: Randomized Controlled Trial of Lifestyle Intervention Postpartum Among Overweight and Obese Women Within Primary Health Care in the Vastra Gotaland Region', 'orgStudyIdInfo': {'id': 'LIV 2011-0193'}, 'secondaryIdInfos': [{'id': 'FORTE LIV', 'type': 'OTHER_GRANT', 'domain': 'FORTE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group receives a brochure on healthy dietary habits according to regular care.'}, {'type': 'EXPERIMENTAL', 'label': 'Dietary intervention', 'description': '12 week individual intervention based on a cognitive behavioral approach. It includes dietary restriction under guidance by a dietitian. Thereafter monthly follow-up takes place via email during the following 9 mo.', 'interventionNames': ['Behavioral: Dietary Intervention']}], 'interventions': [{'name': 'Dietary Intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Dietary intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41458', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Närhälsan Majorna', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '44325', 'city': 'Lerum', 'country': 'Sweden', 'facility': 'Antenatal and child care', 'geoPoint': {'lat': 57.77051, 'lon': 12.26904}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}