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Face-it: Health Promotion for Women With Prior Gestational Diabetes (Face-it)

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ClinicalTrials.gov Identifier: NCT03997773
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborators:
Steno Diabetes Center Odense
Steno Diabetes Center Aarhus
Rigshospitalet, Denmark
Odense University Hospital
Aarhus University Hospital
Aarhus Municipality
Odense Municipality
Copenhagen Municipality
Liva Healthcare A/S
Information provided by (Responsible Party):
Helle terkildsen Maindal, Steno Diabetes Center Copenhagen

Brief Summary:
This project focuses on evaluating a postpartum health promotion intervention among families where the mother has prior gestational diabetes mellitus (GDM). The intervention focuses on the individual, family and health system levels. The aim is to increase quality of life and reduce the risk of type 2 diabetes among women with prior GDM and their families.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Type 2 Diabetes Mellitus Quality of Life Behavioral: Face-it Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm parallel design RCT with women with prior GDM as the unit of randomisation comparing a health promotion intervention with a usual care group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Face-it: A Health Promotion Intervention for Women With Prior Gestational Diabetes and Their Families - A Randomised Controlled Trial
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Will receive the intervention
Behavioral: Face-it Intervention
The Face-it intervention is a health promotion intervention consisting of 3 major components: 1) active involvement of health visitors, 2) digital health technology and coaching, and 3) a structured cross-sectoral communication system in the healthcare system. The intervention will begin at time approx. 3 months (after the baseline data collection, i.e. 10-14 weeks postpartum), and continues until 12 months

No Intervention: Usual care
Will receive usual care - will be the control group



Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) in women with prior GDM [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    To assess changes in BMI, height and body weight will be measured, and calculated kg/m2


Secondary Outcome Measures :
  1. Change in glucose in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Fasting glucose (both women and partner) and 2h OGTT (women only)

  2. Change in HbA1c in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    HbA1c measured in blood sample

  3. Change in insulin in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Insulin secretion and insulin sensitivity

  4. Change in blood pressure in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Systolic and diastolic blood pressure will be measured with the participant in sitting position and with average of three readings measured with two minute intervals.

  5. Change in waist- and hip circumference in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Waist circumference will be measured halfway between the lowest point of the costal margin and highest point of the iliac crest; whereas hip circumference will be measured at the level of the greater femoral trochanter. Both will be measured to the nearest 0.5 cm.

  6. Change in body fat% in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Body fat% will be measured using body impedance

  7. Change in Body Mass Index (BMI) in partners [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    To assess changes in BMI, height and body weight will be measured, and calculated kg/m2

  8. Change in plasma lipids/triglycerides, total cholesterol, HDL, LDL [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Blood samples will be drawn after an overnight fast and will include measures of lipids

  9. Change in quality of life in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Assessed through questionnaire. Quality of life will be measured using the 12-item Short Form Health Survey (SF-12v2). Summary scores will be calculated for both the physical and mental health domains. The SF-12 summary scores range from 0 to 100, with higher scores representing better self-reported health.

  10. Change in well-being in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Assessed through questionnaire. Well-being will be measured with The WHO-Five Well-being Index (WHO-5). An individual score between 0 (worst possible ) and 100 (best possible) is calculated based on the replies to the five questions in the questionnaire.

  11. Change in self-perceived health in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Assessed through questionnaire. Self-perceived Health will be measured using the question "in general, would you say that your health is excellent, very good, good, fair, or poor?".

  12. Change in stress in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Assessed through questionnaire. Stress will be measured with the Perceived Stress Scale (PSS). Individual scores on the PSS ranges from 0 (lowest possible perceived stress level) to 40 (highest possible perceived stress level).

  13. Change in dietary patterns in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Assessed through questionnaire. Dietary patterns will be measured using the Dietary Quality Score (DQS-2017). The score is based on questions regarding intake of fruit, vegetables, fish and fats and is rated on a scale from 0 to 8, with 8 being the most optimal diet.

  14. Change in physical activity patterns in women with prior GDM and their partner [ Time Frame: Measured at baseline and at follow-up 1 year postpartum ]
    Assessed through questionnaire. Physical activity will be measured using adapted version of the International Physical Activity Questionnaire (IPAQ) short form. Physical activity levels will be measured in minutes per week.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with a GDM diagnosis according to current Danish guidelines (2h oral glucose tolerance test ≥9.0mmol/l)
  • Women with a GDM diagnosis should also be attending and giving birth at the obstetric departments at either Aarhus University hospital, Odense University Hospital or Rigshospitalet
  • Partner or infant of women with a GDM diagnosis
  • Able to provide written informed consent in Danish

Exclusion Criteria:

  • Concomitant participation in other postpartum intervention trial with a possible impact on the participation in the face it trial

Withdrawal Criteria:

  • Participant's withdrawal of the informed consent
  • Safety concerns, judged by the investigator
  • Non-compliance with the protocol, judged by the investigator
  • Woman with pGDM being diagnosed with type 1 or type 2 diabetes before or during the first examination (baseline data collection visit)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997773


Contacts
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Contact: Inger Dahl-Petersen, MSc, PhD 004524890764 inger.katrine.dahl-petersen@regionh.dk
Contact: Karoline Kragelund Nielsen, MSc, PhD 004524890764 karoline.kragelund.nielsen@regionh.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Karen Mette Rasmussen Bracken         
Principal Investigator: Per Ovesen, MD, DMSc         
Sub-Investigator: Ulla Kampmann Opstrup, MD, PhD         
Rigshospitalet Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Vibeke Ladefoged         
Principal Investigator: Peter Damm, MD, DMSc         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Ewa Romancsuk         
Principal Investigator: Dorte Moeller Jensen, MD, PhD         
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Steno Diabetes Center Odense
Steno Diabetes Center Aarhus
Rigshospitalet, Denmark
Odense University Hospital
Aarhus University Hospital
Aarhus Municipality
Odense Municipality
Copenhagen Municipality
Liva Healthcare A/S
Investigators
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Principal Investigator: Helle Terkildsen Maindal, MPH, PhD Steno Diabetes Center Copenhagen

Publications:
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Responsible Party: Helle terkildsen Maindal, Professor, Senior Researcher, MPH, PhD, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03997773     History of Changes
Other Study ID Numbers: StenoDC
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helle terkildsen Maindal, Steno Diabetes Center Copenhagen:
Gestational Diabetes
Type 2 Diabetes
Family Intervention
Denmark
Health Promotion
Postpartum Intervention
Quality of Life
Wellbeing
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications