None listed
Conditions
Brief summary
The aim of this study is to determine the feasibility of implementing a pedometer intervention to reduce the incidence of excessive gestational weight gain in pregnant obese women in a cost effective, reliable manner. The results from this feasibility trial will help guide a future large, multicentre randomised trial. In detail, we aim to: 1. Refine and test the trial protocol for a follow-on large multicentre trial; 2. Examine efficacy in increasing activity level to a target of 150 minutes of “fairly active” or “very active” time per week in pregnant obese women via feedback from the Fitbit Zip (registered trademark) pedometer in line with Australian National Physical Activity Guidelines for adults; 3. Examine efficacy in increasing step count at least 150% from baseline measurements (up to 10,000 steps) via feedback from the Fitbit Zip (registered trademark) pedometer; 4. Evaluate the impact of investigator feedback compared with participant self-monitoring alone, on the reduction in excessive gestational weight gain of pregnant obese participants; 5. Confirm earlier trial results, in healthy volunteers, in assessing acceptability of the trial protocol and pedometer use to our patients and antenatal staff, as a high recruitment and participation rate will be required for a viable definitive study; 6. Determine retention rates over the trial period (as dropouts over participants’ pregnancies will significantly limit a future RCT); 7. Assess the magnitude of any effect of the interventions (with particular respect to reducing the incidence of excessive gestational weight gain, and increasing activity and step count levels) to further inform sample size calculation for a definitive trial. Study Outline Thirty obese pregnant women (body mass index greater than or equal to 30 kg/m2 at first clinic booking ) aged 18 years or over, will be supplied with the Fitbit Zip (registered trademark) pedometer and wear it on a daily basis during waking hours until final antenatal visit. Women will be randomised into three groups of 10: 1. Control Group: will wear the pedometer, blinded to daily step counts. 2. Intervention Group A, Pedometer feedback only: will have pedometer “synched” to their personal smartphone, with ability to self-monitor daily step counts. 3. Intervention Group B, Pedometer feedback + behavior change: will have an added behavior change program in addition to pedometer feedback, with additional regular support from study investigators. Participants in groups 2 and 3 will be encouraged to increase their physical activity levels in line with the Australian Physical Activity guidelines for adults, aiming for at least 30 minutes of moderate physical activity most days of the week (or 150 minutes per week). The Fitbit pedometer registers this level of physical activity as “fairly” or “very” active and equates to approximately 10,000 steps per day.
Interventions
Thirty obese pregnant women (body mass index greater than or equal to 30 kg/m2 at first clinic booking ) aged 18 years or over, will be supplied with the Fitbit Zip (registered trademark) pedometer and wear it on a daily basis during waking hours until final antenatal visit. Women will be randomised into three groups of 10: 1. Control Group: will wear the pedometer, blinded to daily step counts. 2. Intervention Group A, Pedometer feedback only: will have pedometer “synched” to their personal smartphone, with ability to self-monitor daily step counts. 3. Intervention Group B, Pedometer feedback + behavior change: will have an added behavior change program in addition to pedometer feedback, with additional regular support from study investigators. Participants in groups 2 and 3 will be encouraged to increase their physical activity levels in line with the Australian Physical Activity guidelines for adults, aiming for at least 30 minutes of moderate physical activity most days of the week (or 150 minutes per week). The Fitbit pedometer registers this level of physical activity as “fairly” or “very” active and equates to approximately 10,000 steps per day. Intervention Group B: In addition to written resources and synching of pedometer data, patients will receive an intervention involving a face-to-face session with a health coach, with follow up telephone and monthly mobile phone text messages (SMS) throughout the intervention until delivery, to remind participants to practice the new behaviours, as used in previous trials. This is based on the successful “HeLP-her” intervention. This intervention is based on self-determination and cognitive behavioural theory, with motivational interviewing the primary method of interaction with participants. The aim will be to support and empower pregnant women to optimise their weight gain during pregnancy. The sessions will progressively educate women about the importance of healthy eating and physical activity during pregnancy, the balance between energy intake and energy expenditure, removing common misconceptions about exercise in pregnancy, increasing confidence about exercise and optimising daily healthy food choices and physical activity throughout pregnancy. Intervention content is underpinned by key components of the behavioural theory including skills of goal setting, action planning and self-monitoring all of which are important factors in long-term behavioural change. The sessions will be interactive and involve practising skills in behaviour change in the form of action planning, removing barriers, identifying enablers, self-monitoring and social persuasion. They will be encouraged to weigh themselves regularly as self-monitoring has been shown through past trials to significantly limit gestational weight gain when coupled with lifestyle intervention. Participants will first attend a one-on-one initial 30 minute assessment session at baseline (16 weeks), followed by one facilitator-led interactive small group session of 60 minutes between 16 and 20 weeks gestation held in the antenatal clinic at Sunshine Hospital. The facilitator will be a trained health coach, trained in the HeLP-her intervention by the developers of the tool at Monash University. Using the topics presented in Session 1 as a guide, participants will be assisted by the facilitator to generate goals and action plans based on their personal priorities, thereby developing a personalised gestational weight gain strategy. At gestational weeks 20 and 24 they will receive a 20 minute telephone coaching session delivered by staff trained in motivational interviewing, which utilise client-orientated counselling to explore and resolve ambivalence and review progress, provide encouragement and assistance and to ensure skills are practiced and action plans are completed. By 28 weeks of pregnancy, participants will have received one face-to-face interactive session, one group intervention and 2 telephone coaching sessions.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Pregnant woman aged 18 years or over 2. Body mass index greater than or equal to 30 kg/m2 at baseline (gestational week 12-15) 3. Recruitment below 20 weeks gestation 4. No mobility impairment (ie. able to ambulate normally without gait aids) 5. Availability of a smartphone capable of allowing Fitbit data uploading (eg. Apple iPhone (registered trademark) or Android (registered trademark) operating system equipped phone).
Exclusion criteria
1. Joint or muscle disorder sufficient to impair walking to a target of 10,000 steps daily. 2. Pre-eclampsia diagnosis 3. Twin or multiple pregnancy 4. Preterm rupture of membranes 5. Incompetent cervix/cerclage