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OBEAT - Beating Obesity

NCT03854331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-01-21

No results posted yet for this study

Summary

The primary objective of this trial is to study the feasibility of a resilience intervention to reduce stress and thus improve sleep, healthy diet and physical activity in normal weight pregnant women.

Initially, an exploratory study of stressors and worrying in pregnant women will be done by use of qualitative methods (focus group interviews) followed by a randomised controlled feasibility trial with a parallel qualitative process evaluation.

This project is expected to improve the understanding of the processes and feasibility of conducting a randomized intervention study to examine if improvements in chronic stress and poor sleep during pregnancy improves early weight gain and childhood risk of obesity.

Conditions

  • Pregnancy Related
  • Obesity, Childhood
  • Stress

Interventions

BEHAVIORAL

Resilience program

The resilience program consists of different modules that are based on research on mentalization, mindfulness, parent management training, improving self-control and self-efficacy, cognitive behaviour therapy, social learning theory and neuroscience. The MyResilience program is also informed by cognitive bias modification and self-control training research. These techniques have been found to be effective in improving engagement in health behaviours and reducing symptoms and negative behaviours in clinical groups

Sponsors & Collaborators

  • TRYG Foundation

    collaborator OTHER

  • Oak Foundation

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Berit Heitmann, Professor · Research Unit for Dietary Studies at The Parker Institute Bispebjerg and Frederiksberg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2020-06-25
Completion
2020-10-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854331 on ClinicalTrials.gov