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A cluster randomised trial to evaluate the effectiveness of a telephone based coaching program in reducing excessive gestational weight gain amongst pregnant women

Evaluation of a telephone based information and coaching program to reduce excessive gestational weight gain amongst pregnant women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000397516
Enrollment
640
Registered
2015-04-29
Start date
2014-09-02
Completion date
2015-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Excessive gestational weight gain (EGWG) or weight gain during pregnancy is associated with poor child and maternal health outcomes, including preeclampsia, gestational diabetes, complications with labour and delivery, and babies who are born either small or large for gestational age. There is also an increased likelihood of postpartum obesity in both mothers and their children, which in turn leads to an increased risk of chronic disease later in life. Estimates from one off studies indicate the prevalence of EGWG in Australia could lie between 38 and 67%. The NSW Get Healthy Service (GHS) is a telephone based coaching service available to all adults in NSW aged 18 years and over. The NSW Office of Preventive Health (OPH) and NSW Kids and Families have collaborated to develop a service enhancement or “module” for the GHS specifically aimed at supporting pregnant women to achieve appropriate gestational weight gain. An initial pilot phase for the module is proposed to assess effectiveness of the coaching program, through conduct of a randomised controlled trial. This RCT will compare the effectiveness of a telephone based coaching program versus provision of information alone in supporting pregnant women to achieve appropriate gestational weight gain and prevent postpartum weight retention. The hypothesis is that compared with participants who only receive information, pregnant women enrolled in the coaching program will be less likely to achieve excessive gestational weight, and be more likely to have returned to their prepregnancy weight 12 months after giving birth. A stratified cluster randomised design will be used, with stratification by prepregnancy BMI (normal and overweight/obese) and clustering by hospital. Four hospitals will be invited to participate, with two allocated to the control arm and two to the intervention arm. Pregnant women will be invited to participate in the trial on their first booking visit with a midwife, and allocated to an arm depending on the hospital they attend. Anthropometric (e.g. weight gain or retention) and behavioural (e.g. fruit and vegetable consumption) outcomes for each group will be compared at 36 weeks gestation and 12 months post birth. Additionally, qualitative feedback on the feasibility and acceptability of the module (information and coaching components) will be sought from participants and midwives.

Interventions

Women in the intervention group will be enrolled in a coaching program run by the Get Healthy Service which has been adapted specifically for pregnant women (the GWG module). The coaching program comprises up to 10 calls between 15 - 40 minutes in duration by university qualified coaches (8 during pregnancy and 2 after birth). The length is directed by the participant, and can be flexible. Similar to the standard GHS, the calls are aimed at healthy eating, physical activity and achieving health

Women in the intervention group will be enrolled in a coaching program run by the Get Healthy Service which has been adapted specifically for pregnant women (the GWG module). The coaching program comprises up to 10 calls between 15 - 40 minutes in duration by university qualified coaches (8 during pregnancy and 2 after birth). The length is directed by the participant, and can be flexible. Similar to the standard GHS, the calls are aimed at healthy eating, physical activity and achieving healthy weight gain during pregnancy. Calls are based on behaviour change principles designed to help with goal setting, maintaining motivation, overcoming barriers and making sustainable life changes. The timing of calls is designed to be flexible based on participant preferences. Generally, the schedule for calls pre-delivery: 3 calls in the first 3 weeks, followed by a call every 2-3 weeks, unless requested otherwise from the participant. For post pregnancy calls: 1 call at 10 weeks, 1 call at 14 weeks post delivery, unless requested otherwise by the participant. Participants in the coaching arm will receive 10 calls: 8 during pregnancy, 2 post pregnancy. Fewer calls may be conducted if the woman withdraws from the Service, or delivers before her 7th call. Compliance to the study will be monitored by recording the number and dates of coaching calls received by a participant and recording reason for withdrawing from the Service in the case of withdrawals Participants in the coaching program will also be provided with evidence based materials including pregnancy specific fact sheets, the Having a Baby Book published by NSW Health and the Get Healthy Information booklet which includes generic advice on healthy eating, physical activity and achieving and maintaining a healthy weight. All pregnancy specific content is developed based on nationally and internationally endorsed guidelines such as the Australian Dietary Guidelines and US Institute of Medicine Weight Gain during Pregnancy guidelines.

Sponsors

NSW Office of Preventive Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Pregnant women Women with conditions that may potentially require minor adaptation of the standard dietary or physical activity to participate in the program safely will require clearance from a medical practitioner. All conditions are listed in the protocol. Some examples of conditions that require medical clearance include: Hypertension Epilepsy Asthma Moderate (women requiring daily bronchodilators and steroid inhalers) Type 2 diabetes (diet controlled) Musculo-skeletal problems Previous pre-term birth Recurrent miscarriage (Note that this is not an exhaustive list)

Exclusion criteria

1. Pre-pregnancy BMI < 18.5 kg/m2; 2. Gestation of over 18 weeks; 3. Non English speaking; 4. Multiple pregnancy; and 5. Women with complex medical conditions

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026