OBEAT - Beating Obesity

NCT03854331 | Completed DMC

• 1 other identifier: TRYG-125690
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Resilience; Cortisol; Feasibility; Healthy lifestyle; Sleep

Outcome Measures

Primary Outcomes (7)

• Recruitment-rates - feasibility

  Number of participants out of eligible pregnant women approached

  Two months after birth

• Recruitment-time - feasibility

  Number of days used to recruit the decided number of 120 participants

  Two months after birth

• Attrition-rates - feasibility

  Number of participants leaving the study before the end

  Two months after birth

• Follow up-rates - feasibility

  Number of participants in final clinical examination

  Two months after birth

• Compliance-rates - feasibility

  Use of resilience program measured from web-statistics

  Two months after birth

• Self-reported compliance-rates - feasibility

  Use of resilience program from patient-reported questionnaire

  Two months after birth

• Satisfaction-rates - feasibility

  Measured from patient-reported questionnaire

  Two months after birth

Secondary Outcomes (17)

• Change in maternal chronic stress

  Gestational week 14-18, 28, 35, birth and two months after birth

• Change in maternal perceived stress

  Gestational week 14-18, 28, 35 and two months after birth

• Change in maternal depression, anxiety and tension/stress.

  Gestational week 14-18, 28, 35 and two months after birth

• Change in mentalization ability

  Gestational week 14-18, 28, 35 and two months after birth

• Changes in maternal Sense of Coherence (SOC)

  Gestational week 14-18, 28, 35 and two months after birth

Other Outcomes (8)

• Diet - infant (breastfeeding, bottlefeeding)

  Two months after birth

• Infant crying

  Two months after birth

• Differences in infant chronic stress

  Birth and two months after birth

Study Arms (2)

Resilience program

EXPERIMENTAL

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

Behavioral: Resilience program

Standard care

NO INTERVENTION

Danish antenatal standard care is 3 visits at the general practitioner, 5 midwife controls and 2 ultrasound scans

Interventions

Resilience program BEHAVIORAL

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

Resilience program

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Expecting first child
• Speaks Danish
• Non-obese (BMI \< 30)
• Singleton pregnancy
• Visited to basic level midwife care

You may not qualify if:

• Non-danish speakers
• Type 1 or 2 diabetes
• Visited to specialist midwife care for psychosocial reasons
• Expecting twins
• BMI \> 30
• Multipara

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• TRYG Foundation: collaborator
• Oak Foundation: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

• Ladekarl M, Olsen NJ, Winckler K, Brodsgaard A, Nohr EA, Heitmann BL, Specht IO. Early Postpartum Stress, Anxiety, Depression, and Resilience Development among Danish First-Time Mothers before and during First-Wave COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Nov 9;18(22):11734. doi: 10.3390/ijerph182211734.

  PMID: 34831493 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Berit Heitmann, Professor

  Research Unit for Dietary Studies at The Parker Institute Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal investigator

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 26, 2019
• Study Start: June 18, 2019
• Primary Completion: June 25, 2020
• Study Completion: October 28, 2020
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

DK (1)