The eHealth Integrated Maternal Physical Activity Programme in Prenatal Care Trial (E-IMPACT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorKK Women's and Children's Hospital
About this trial
This will be a proof-of-concept randomised control trial (RCT) study, where 100 pregnant women will be recruited in the first trimester of pregnancy and followed-up until delivery. It aims to test these following hypotheses:
1. pregnancy is a window of opportunity to implement good lifestyle habits of physical activity and exercise as pregnant women are in regular contact with health professionals and are likely motivated and be more confident to carry out these activities according to the guidelines 2. this integrated programme will effective in a healthcare setting, and will bring Singapore's "Guidelines on Physical Activity and Exercise in Pregnancy" guidelines to implementation 3. with enhanced self-efficacy and motivation, the proportion of women engaging in adequate physical activity during pregnancy will increase to meet recommended guidelines.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women (First trimester at least 4 weeks gestation)
Age 21 years and above
BMI 23 kg/m2 and above
Physically fit to participate in moderate intensity exercise
Disqualifiers
Women who have severe chronic disease such as chronic kidney disease, hypertension, asthma OR
Obstetric or medical complications which might preclude women in normal levels of physical activity or exercise during pregnancy.
Women who participated in other weight management programmes, or physical activity intervention studies recently (past 6 months) or concurrently
Difficulty in understanding the English language
Trial design
Design model
Parallel
Treatments tested in this trial
e-IMPACT programme
Behaviorala three-part prenatal physical activity intervention delivered across all trimesters. It includes telehealth one-on-one consultations using Motivational Interviewing and SMART goal-setting, wearable trackers for self-monitoring, and guideline-based educational content via pre-recorded digital videos.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: e-IMPACT GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assessment of meeting physical activity guidelines at 12 weeks from baseline (between 19 to 23 weeks gestational age)
Objective measures of steps, moderate-to-vigorous physical activity and activity duration and energy expenditure (AEE) will be assessed using an activity tracker to capture physical activity engagement, sedentary time and energy expenditure (MET-min/day).
Time frame
At 12 weeks from baseline (between 19 to 23 weeks gestational age)2
Assessment of meeting physical activity guidelines at 24 weeks from baseline (from 31 to 35 weeks gestation)
Objective measures of steps, moderate-to-vigorous physical activity and activity duration and energy expenditure (AEE) will be assessed using an activity tracker to capture physical activity engagement, sedentary time and energy expenditure (MET-min/day).
Time frame
At 24 weeks from baseline (from 31 to 35 weeks gestation)Secondary outcomes
1
Assessing the feasibility, acceptability, and scalability of the study programme at 24 weeks from baseline (between 31 to 35 weeks gestation)
Survey for only participants in the intervention group.
Time frame
At 24 weeks from baseline (between 31 to 35 weeks gestation)Other outcomes
1
Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at baseline (between 7 to 11 weeks gestation)
Using the validated Pregnancy Exercise Self- Efficacy Scale. Total scores range from 10 to 50, with higher scores indicating greater exercise self-efficacy during pregnancy.
Time frame
At baseline ( between 7 to 11 weeks gestation)2
Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at 12 weeks from baseline (between19 to 23 weeks gestation)
Using the validated Pregnancy Exercise Self- Efficacy Scale. Total scores range from 10 to 50, with higher scores indicating greater exercise self-efficacy during pregnancy.
Time frame
At 12 weeks from baseline (between19 to 23 weeks gestation)3
Assess participants' self-efficacy beliefs related to engaging in exercise during pregnancy at 24 weeks from baseline (between 31 to 35 weeks gestation)
Using the validated Pregnancy Exercise Self- Efficacy Scale. Total scores range from 10 to 50, with higher scores indicating greater exercise self-efficacy during pregnancy.
Time frame
At 24 weeks from baseline (between 31 to 35 weeks gestation)4
Assess participants' self- motivation related to engaging in exercise during pregnancy at baseline (between 7 to 11 weeks gestation)
Using validated Behavioural Regulation in Exercise Questionnaire (BREQ-2). Scores range from 0 to 4 for each subscale, with higher scores reflecting stronger endorsement of that type of exercise motivation.
Time frame
At baseline ( between 7 to 11 weeks gestation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
KK Women's and Children's Hospital
Lead sponsor
National University of Singapore
Collaborator
Source ClinicalTrials.gov