Clinical trial NCT03854331: OBEAT - Beating Obesity
Official title: OBEAT - Beating Obesity: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Obesity, Childhood
Stress
Keywords: Resilience
Cortisol
Feasibility
Healthy lifestyle
Sleep
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
name: Oak Foundation
name: Hvidovre University Hospital
First posted: 2019-02-26
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Phase 1: Planning In Phase 1 (6 months), the project will be developed and planned, and approvals from the Danish Data Protection Agency and Ethical Committee of the Capital Region to conduct the study will be obtained.

Validated questionnaires to measure perceived stress, sleep patterns, physical activity- and dietary habits will be selected and pilot tested.

Phase 2: Recruitment and data collection In Phase 2 (12 months), participants will be recruited and randomized. Pregnant women living in Denmark are offered public, antenatal care delivered by hospital employed midwives. Healthy, non-obese, pregnant women assigned to antenatal care and birth at Hvidovre Hospital, are routinely invited to a first antenatal midwife session at gestational week 14-18. At these sessions, participants will be informed and recruited to the feasibility study. In 8 weeks approximately 240 pregnant women will be eligible, thus 120 women corresponding to 50% of all eligible pregnant women in one month will be recruited. In this feasibility study 50% of the women will be randomised to the intervention group and introduced to the resilience internet-based program/ smart phone app and 50% will be randomised to the control group and receive standard care. Computer-based randomization procedures will be used.

Phase 3: Feasibility study evaluation In Phase 3 (19 months), the knowledge obtained in Phase 2 will be evaluated.

An effect evaluation of the project will be conducted by analysing the collected clinical data, primarily related to changes and correlations in chronic stress in mother and infant (measured by hair cortisol), perceived stress, physical activity- and dietary habits, infant birth length and weight, and gestational age.

A process evaluation will also be conducted. The Committee of Health Education will collect data on how much and what parts of the resilience program has been used by the participating pregnant women. In addition, the participants will be asked to complete a short questionnaire on how frequent and how satisfied they have been with using the program. The researchers also want to use qualitative focus group interviews to investigate the participants' attitudes and acceptability of the proposed intervention.

The results of the effect- and process evaluations will be synthesized and will, depending on the results of the feasibility study, be implemented in a following planning of a large RCT.

Qualitative analytical methods The interview guide will be developed based on a literature search of existing literature in the field. To minimize the bias of my own influence I will consider my own experience and pre-understanding as a midwife.

The interviews will be recorded digitally and subsequently transcribed literally. The data will be analyzed using content analysis as described by Graneheim \& Lundman. The purpose of the content analysis is to organize and understand the meaning of the data collected in the focus group interviews and to draw conclusions from it.

Statistical analysis The clinical outcomes will be examined using paired t-tests as well as linear or logistic regression analyses. Analyses will be done crude and adjusted for potential confounders obtained from the completed questionnaires. Results of the analyses of the clinical outcomes are expected to be underpowered due to the feasibility design of this study but will however provide estimates indicating any direction or effect size of the resilience program on this target group.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment-rates - feasibility
timeFrame: Two months after birth
measure: Recruitment-time - feasibility
timeFrame: Two months after birth
measure: Attrition-rates - feasibility
timeFrame: Two months after birth
measure: Follow up-rates - feasibility
timeFrame: Two months after birth
measure: Compliance-rates - feasibility
timeFrame: Two months after birth
measure: Self-reported compliance-rates - feasibility
timeFrame: Two months after birth
measure: Satisfaction-rates - feasibility
timeFrame: Two months after birth
Secondary outcomes:
measure: Change in maternal chronic stress
timeFrame: Gestational week 14-18, 28, 35, birth and two months after birth
measure: Change in maternal perceived stress
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Change in maternal depression, anxiety and tension/stress.
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Change in mentalization ability
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Changes in maternal Sense of Coherence (SOC)
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Changes in maternal resilience
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Differences in parental stress
timeFrame: Two months after birth
measure: Changes in fear of childbirth
timeFrame: Gestational week 14-18, 28, 35
measure: Changes in fetal health anxiety
timeFrame: Gestational week 14-18, 28, 35
measure: Sleep patterns - mother
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Changes in participant's physical activity - transportation
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Changes in participant's physical activity - exercise
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Changes in diet - mother
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Weight - mother
timeFrame: Gestational week 14-18, 28, 35 and two months after birth
measure: Weight - child
timeFrame: Birth and two months after birth
measure: Length - child
timeFrame: Birth and two months after birth
measure: Head circumference - child
timeFrame: Birth and two months after birth
Other outcomes:
measure: Diet - infant (breastfeeding, bottlefeeding)
timeFrame: Two months after birth
measure: Infant crying
timeFrame: Two months after birth
measure: Differences in infant chronic stress
timeFrame: Birth and two months after birth
measure: Differences in birth method
timeFrame: Birth
measure: Differences in epidural-rate
timeFrame: Birth
measure: Differences in rates of prolonged labour
timeFrame: Birth
measure: Differences in use of private healthcare providers
timeFrame: Gestational week 14-18, 28, 35, birth and two months after birth
measure: Differences in absence from work during pregnancy
timeFrame: Gestational week 14-18, 28, 35
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
Study officials:
affiliation: Research Unit for Dietary Studies at The Parker Institute Bispebjerg and Frederiksberg Hospital
name: Berit Heitmann, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.