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 : May 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gestational Diabetes Type 2 Diabetes Mellitus Quality of Life | Behavioral: Face-it Intervention | Not Applicable |

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 : | August 30, 2023 |
Estimated Study Completion Date : | August 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Will receive the intervention
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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
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- 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
- 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)
- 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
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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.
- 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.
- 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?".
- 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).
- 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.
- 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 |
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)

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
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 |
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 |
Principal Investigator: | Helle Terkildsen Maindal, MPH, PhD | Steno Diabetes Center Copenhagen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Helle terkildsen Maindal, Professor, Senior Researcher, MPH, PhD, Steno Diabetes Center Copenhagen |
ClinicalTrials.gov Identifier: | NCT03997773 |
Other Study ID Numbers: |
StenoDC |
First Posted: | June 25, 2019 Key Record Dates |
Last Update Posted: | May 11, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gestational Diabetes Type 2 Diabetes Family Intervention Denmark |
Health Promotion Postpartum Intervention Quality of Life Wellbeing |
Diabetes, Gestational Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pregnancy Complications |