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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 : December 4, 2020
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

Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE May 21, 2019
Estimated Primary Completion Date January 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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-12).
  • 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).
  • 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).
  • 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).
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Face-it: Health Promotion for Women With Prior Gestational Diabetes
Official Title  ICMJE Face-it: A Health Promotion Intervention for Women With Prior Gestational Diabetes and Their Families - A Randomised Controlled Trial
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.
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 postpartum. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Gestational Diabetes
  • Type 2 Diabetes Mellitus
  • Quality of Life
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Intervention
    Will receive the intervention
    Intervention: Behavioral: Face-it Intervention
  • No Intervention: Usual care
    Will receive usual care - will be the control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2023
Estimated Primary Completion Date January 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997773
Other Study ID Numbers  ICMJE StenoDC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helle terkildsen Maindal, Steno Diabetes Center Copenhagen
Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Helle Terkildsen Maindal, MPH, PhD Steno Diabetes Center Copenhagen
PRS Account Steno Diabetes Center Copenhagen
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP