- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997773
Face-it: Health Promotion for Women With Prior Gestational Diabetes (Face-it)
Face-it: A Health Promotion Intervention for Women With Prior Gestational Diabetes and Their Families - A Randomised Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Face-it: A Health Promotion Intervention for Women with Prior Gestational Diabetes and their Families
AIM: The aim of the Face-it project is to increase quality of life and reduce the risk of type 2 diabetes (T2DM) among women with prior gestational diabetes mellitus (pGDM) and their families.
BACKGROUND: Women with pGDM are at high risk of developing type 2 diabetes. Partners and offspring of women with GDM are also at elevated risk of developing type 2 diabetes and related cardiometabolic conditions. Thus, not only are women with prior GDM at high risk of T2DM and related cardiometabolic conditions, their children and spouses are as well. Since the cumulative incidence of T2DM increases substantially within the first five years after delivery (Kim et al. 2002) there is a strong interest in identifying feasible and effective interventions in this time-period. Evidence from the state-of-the-art Diabetes Prevention Program suggests that intensive lifestyle intervention can reduce the risk of T2DM among women with pGDM (Ratner et al. 2008). However, sustainable changes in such behaviours are difficult and many women do not follow lifestyle recommendations after delivery (Stage et al. 2004). Given the highly elevated risk in this group, this is a substantial missed opportunity for health promotion aimed at prevention of T2DM for not only the mother, but the entire family. It is vital that efforts are based on a thorough understanding of the barriers to health promoting behaviours and involve carefully tailored solutions to overcome these barriers. The investigators hypothesise that a health promotion intervention that focuses on enhancing motivation, health literacy, action competences and social involvement in women with pGDM and their families will reduce diabetes risk and improve quality of life.
DESIGN: Face-it is a two-arm parallel-group randomised clinical trial with women as the unit of randomization comparing a health promotion intervention with a usual care control group.
PARTICIPANTS, RECRUITMENT AND ELIGIBILIGY: Women with pGDM will be recruited from obstetric departments at Aarhus University Hospital (AUH), Odense University Hospital (OUH) or Rigshospitalet (RH) around 24-40 weeks of pregnancy by a health care professional. To be eligible for enrolment into the study, women should also be able to provide written informed consent in Danish. Exclusion criteria is that the participants may not be participating in other postpartum intervention trials with a possible impact on the Face-it trial. Women with diabetes identified at baseline will be excluded. Partners of women and the new-born offspring are also invited to participate in the study. Informed consents are obtained from 1) woman and new-born offspring, including permission to obtain information from the medical record and blood samples for research biobank (woman only), 2) from partner, including blood samples for research biobank. A separate consent 3) is obtained for collection of blood for future biobank. In case of non-participation in the study, women are asked for consent to collect information from the medical record including health characteristics of woman and offspring related to pregnancy and birth.
SAMPLE SIZE AND RANDOMISATION: Based on prior studies, a mean difference in BMI after 1 year between the intervention and control groups for the women of -1.0 kg/m2 and standard deviation of 2.5 is expected. A sample size of 225 women will be required to detect such a difference in BMI when using a 2:1 randomisation procedure, a power of at least 80% and type 1 error of 5% (two-sided). The sample size increases to 460 women to allow for assuming 30% loss to follow-up between baseline and follow-up and another 30% will withdraw during the prolonged period from recruitment to baseline data collection and randomisation.
1/3 of participants will be randomised to the control group and 2/3 to the intervention group. The randomization procedure has been generated by an independent statistician and will be in blocks of 6/9/12/15 with a separate randomization at each of the three recruitment locations. Allocation will be concealed from both the participant and the investigators, who have the clinical and research responsibility, until baseline data have been collected, eligibility confirmed, and participation accepted. However, neither participants nor the investigators will be blinded to the participants intervention or control status after this point, but the status will be blinded for the analyst. A randomization list will be kept securely at the study site by an investigator with clinical responsibility. Both the intervention and usual care group will be part of the evaluation of the Face-it trial and therefore invited to baseline and follow-up clinical examinations. Participants will be informed by a research assistant about whether they have been allocated to the control or intervention group.
INTERVENTION: The intervention has been developed in a thorough and iterative co-creation process with health care providers and families, where the mothers has pGDM to ensure that it is carefully tailored to the needs and challenges of the target group and enhance its sustainability. The three major components of the intervention are: 1) Health visitors as the core healthcare providers, 2) digital health technology, and 3) a structured cross-sectoral communication system in the healthcare system.
CONTROL: Participants in the control group will receive usual care practice, including recommended glucose control measures 3 months and one year after birth. Participants will receive advice about a healthy lifestyle according to the national recommendations from the Danish Health and Medicines Authority . Participants in the control group will be invited to participate in the health examination at baseline and follow-up and thereby obtain information about own health when attending the two clinical examinations.
STUDY PROCEDURES AND DATA COLLECTION: There are two study visits planned for each participant (women with pGDM, her partner and baby). Visit 1 (baseline) will take place 10-14 weeks postpartum. Visit 2 (follow-up) will take place around 12 months after delivery. The measurements taken at the visits are dependent on whether the participant is a women with pGDM, partner or offspring.
- 75g oral glucose tolerance test (OGTT) with measurements of glucose and insulin at 0, 30 and 120 minutes (women with pGDM only)
- Blood samples including fasting glucose, insulin secretion and insulin sensitivity Index, hbA1c, plasma lipids/ triglycerides, total cholesterol, HDL, LDL (women with pGDM and partners)
- Physical measures. Investigations on women with pGDM and their partners will include BMI, height, weight, waist- and hip circumference, body fat, blood pressure.
- Physical measures on offspring will include height, weight, abdominal- and head circumference (at one-year follow-up).
- Questionnaire. Detailed information will be collected about socio-demographic and -economic details, dietary-, physical activity-, and sleep patterns; quality of life, stress, depression, self-perceived health, health literacy, motivation for behaviour change, social support, self-efficacy, risk perception and knowledge about diabetes risk in women with pGDM and their partners. Information about obstetric history and breastfeeding will also be collected from women with pGDM
- Objective measures of physical activity and sedentary patterns (subgroup)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Inger Dahl-Petersen, MSc, PhD
- Phone Number: 004524890764
- Email: inger.katrine.dahl-petersen@regionh.dk
Study Contact Backup
- Name: Karoline Kragelund Nielsen, MSc, PhD
- Phone Number: 004524890764
- Email: karoline.kragelund.nielsen@regionh.dk
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University Hospital
-
Copenhagen, Denmark, 2100
- Rigshospitalet
-
Odense, Denmark, 5000
- Odense University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Will receive the 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Mass Index (BMI)
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
To assess changes in BMI, height and body weight will be measured, and calculated kg/m2
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in quality of life
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.
Quality of life will be measured using the 12-item Short Form Health Survey (SF-12v2).
Summary score will be calculated for the mental health domain.
The SF-12 summary score ranges from 0 to 100, with higher scores representing better self-reported quality of life/health.
|
Measured at baseline and at follow-up 1 year after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fasting glucose
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Fasting glucose (mmol/L)
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in HDL and triglycerides
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Blood samples will be drawn after an overnight fast and will include measures of lipids
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in well-being
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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.
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in self-perceived health
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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?".
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in stress
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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).
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in anxiety
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.
Anxiety will be measured with the General Anxiety Disorder (GAD-7) scale.
Individual scores on the GAD-7 ranges from 0 (lowest possible anxiety level) to 21 (highest possible anxiety level).
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in dietary patterns
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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.
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in moderate to vigorous physical activity patterns
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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.
|
Measured at baseline and at follow-up 1 year after delivery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in waist- and hip circumference in women with prior GDM
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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.
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in body fat% in women with prior GDM
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Body fat% will be measured using body impedance
|
Measured at baseline and at follow-up 1 year after delivery
|
Differences in %weight change
Time Frame: At follow-up 1 year after delivery
|
Weight will be measured at baseline and 1 year after delivery, and the %weight change calculated
|
At follow-up 1 year after delivery
|
Change in 2h glucose
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
After 2h OGTT
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in HbA1c (mmol/mol)
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
HbA1c measured in fasting blood sample
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in fasting and 2h insulin (pmol/L)
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Measure in fasting blood sample and after 2h OGTT
|
Measured at baseline and at follow-up 1 year after delivery
|
Changes in HOMA-IR and HOMA-b
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Will be calculated based on the glucose and insulin measurements
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in blood pressure
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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.
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in total cholesterol and LDL
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Blood samples will be drawn after an overnight fast and will include measures of lipids
|
Measured at baseline and at follow-up 1 year after delivery
|
Impaired fasting glucose (IFG) and impaired glucose tolerance (IGT)
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
IFG and IGT will be assessed based on the glucose measurements
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in physical health quality of life
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.
Quality of life will be measured using the 12-item Short Form Health Survey (SF-12v2).
Summary score will be calculated for the physical health domain.
The SF-12 summary score ranges from 0 to 100, with higher scores representing better self-reported quality of life/health.
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in walking patterns physical activity
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
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.
|
Measured at baseline and at follow-up 1 year after delivery
|
Differences in breastfeeding duration
Time Frame: Measured at follow-up 1 year after delivery
|
Assessed through questionnaire.
|
Measured at follow-up 1 year after delivery
|
Changes in social support for diet and exercise
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.Will be measured using the Social Support and Eating Habits and Social Support and Exercise scales.
Higher scores indicate more social support.
|
Measured at baseline and at follow-up 1 year after delivery
|
Changes in exercise self-regulation and motivation
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.Will be measured using the TSRQ.
Higher scores indicate higher self-regulation and motivation.
|
Measured at baseline and at follow-up 1 year after delivery
|
Change in self-efficacy
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.Will be measured using the General Self-efficay scale.
Higher scores indicate higher self-efficay.
|
Measured at baseline and at follow-up 1 year after delivery
|
Changes in risk perception
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.Will be measured using the RPS-DD questionnaire.
|
Measured at baseline and at follow-up 1 year after delivery
|
Changes in health literacy
Time Frame: Measured at baseline and at follow-up 1 year after delivery
|
Assessed through questionnaire.Will be measured using the HLQ.
Higher scores indicate higher health literacy.
|
Measured at baseline and at follow-up 1 year after delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Helle Terkildsen Maindal, MPH, PhD, Steno Diabetes Center Copenhagen
Publications and helpful links
General Publications
- Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.
- Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE; Diabetes Prevention Program Research Group. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008 Dec;93(12):4774-9. doi: 10.1210/jc.2008-0772. Epub 2008 Sep 30.
- Stage E, Ronneby H, Damm P. Lifestyle change after gestational diabetes. Diabetes Res Clin Pract. 2004 Jan;63(1):67-72. doi: 10.1016/j.diabres.2003.08.009.
- Maindal HT, Timm A, Dahl-Petersen IK, Davidsen E, Hillersdal L, Jensen NH, Thogersen M, Jensen DM, Ovesen P, Damm P, Kampmann U, Vinter CA, Mathiesen ER, Nielsen KK. Systematically developing a family-based health promotion intervention for women with prior gestational diabetes based on evidence, theory and co-production: the Face-it study. BMC Public Health. 2021 Sep 3;21(1):1616. doi: 10.1186/s12889-021-11655-2.
- Nielsen KK, Dahl-Petersen IK, Jensen DM, Ovesen P, Damm P, Jensen NH, Thogersen M, Timm A, Hillersdal L, Kampmann U, Vinter CA, Mathiesen ER, Maindal HT; Face-it Study Group. Protocol for a randomised controlled trial of a co-produced, complex, health promotion intervention for women with prior gestational diabetes and their families: the Face-it study. Trials. 2020 Feb 7;21(1):146. doi: 10.1186/s13063-020-4062-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- StenoDC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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