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

NCT03997773 | Completed

• 1 other identifier: StenoDC
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 3

Brief Summary

This project focuses on evaluating a health promotion intervention among families where the mother has prior gestational diabetes mellitus (GDM) in the first year after delivery. 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.

Conditions

Gestational Diabetes; Type 2 Diabetes Mellitus; Quality of Life

Keywords

Gestational Diabetes; Type 2 Diabetes; Family Intervention; Denmark; Health Promotion; Postpartum Intervention; Quality of Life; Wellbeing

Outcome Measures

Primary Outcomes (2)

• Change in Body Mass Index (BMI)

  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

  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 Outcomes (8)

• Change in fasting glucose

  Measured at baseline and at follow-up 1 year after delivery

• Change in HDL and triglycerides

  Measured at baseline and at follow-up 1 year after delivery

• Change in well-being

  Measured at baseline and at follow-up 1 year after delivery

• Change in self-perceived health

  Measured at baseline and at follow-up 1 year after delivery

• Change in stress

  Measured at baseline and at follow-up 1 year after delivery

Other Outcomes (18)

• Change in waist- and hip circumference in women with prior GDM

  Measured at baseline and at follow-up 1 year after delivery

• Change in body fat% in women with prior GDM

  Measured at baseline and at follow-up 1 year after delivery

• Differences in %weight change

  At follow-up 1 year after delivery

Study Arms (2)

Intervention

EXPERIMENTAL

Will receive the intervention

Behavioral: Face-it Intervention

Usual care

NO INTERVENTION

Will receive usual care - will be the control group

Interventions

Face-it Intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Steno Diabetes Center Odense: collaborator
• Aarhus University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Aarhus Municipality, Denmark: collaborator
• Odense Municipality: collaborator
• Copenhagen Municipality, Denmark: collaborator
• Liva Healthcare A/S: collaborator

Study Sites (3)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (6)

• 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.

  PMID: 12351492 BACKGROUND

• 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.

  PMID: 18826999 BACKGROUND

• 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.

  PMID: 14693414 BACKGROUND

• Jensen NH, Kragelund Nielsen K, Dahl-Petersen IK, Kampmann U, Damm P, Ovesen P, Mathiesen ER, Vinter CA, Davidsen E, Thogersen M, Timm A, Andersen LLT, Knorr S, Jensen DM, Maindal HT. Health promotion intervention among women with recent gestational diabetes mellitus: penetration, participation, and baseline findings from the Face-it randomized controlled trial. BMJ Open Diabetes Res Care. 2023 Oct;11(5):e003529. doi: 10.1136/bmjdrc-2023-003529.

  PMID: 37793679 DERIVED

• 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.

  PMID: 34479526 DERIVED

• 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.

  PMID: 32033613 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Helle Terkildsen Maindal, MPH, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Researcher, MPH, PhD

Model Details: 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

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 25, 2019
• Study Start: May 16, 2019
• Primary Completion: June 6, 2023
• Study Completion: June 30, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)