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A lifestyle intervention to prevent gestational weight gain: will it effect infant obesity?

Evaluating the effectiveness of a dietary and lifestyle intervention in reducing excessive gestational weight gain in obese pregnant women, and determining the effect on infant obesity.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000414213
Enrollment
440
Registered
2018-03-21
Start date
2017-06-01
Completion date
2020-02-06
Last updated
2021-10-18

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

Conditions

None listed

Brief summary

Overweight and obesity are major global public health issues identified to contribute to disease burden by increasing the risk of diabetes and cardiovascular disease and their associated complications. Over half the adult female Australian population are classified as being overweight or obese with women of reproductive age having one of the highest rates of weight gain in Australia. At Westmead Hospital in 2014/15, 42.7% of the 5600 women who gave birth there were overweight or obese, approximately 50% had excessive gestational weight gain (GWG) and over 400 developed gestational diabetes. There are a number of well documented adverse outcomes associated with excessive weight gain and overweight and obesity during pregnancy and these risks increase with increasing BMI. Furthermore, growing evidence indicates the fetus of an overweight mother on an unhealthy diet is ‘programmed’ via epigenetics to lifelong obesity and ill-health. Interventions to prevent childhood obesity must begin during pregnancy. Women who are able to keep their gestational weight gain to within the recommended limits, whether obese or of normal weight, show significantly reduced rates of foetal and maternal complications. Due to the frequency of contact of health professions during the antenatal period, it is an ideal time to take the opportunity to intervene and make changes that mothers perceive will optimise the outcome for themselves and their offspring. A recent Cochrane review (2015), indicated that intense diet and exercise can reduce the risk of excessive GWG, with some studies reporting 5kg lower GWG, and a significant reduction in macrosomia, which has obvious implications for neonatal adiposity. Furthermore, it has been shown that the use of SMS text messaging are effective in promoting weight loss and appropriate GWG. We hypothesize that an early and intense dietary and lifestyle intervention, i.e. utilising frequent patient contact via mobile phone technology and face-to-face support, will reduce GWG, GDM, post-partum weight retention and infant adiposity, compared to standard antenatal care.

Interventions

Clients that have consented to participate will be randomly allocated to the Intervention or the Control group. There will be 282 participants in each group. Women randomised to the Intervention group will complete questionnaires including questions from the NSW Population Health Survey (2105), 24h food recall, an Active Australia Questionnaire and Edinburgh Depression scale. Initial dietetic consultations for each of the participants is educational and advice based, and lasts for 45 approximat

Clients that have consented to participate will be randomly allocated to the Intervention or the Control group. There will be 282 participants in each group. Women randomised to the Intervention group will complete questionnaires including questions from the NSW Population Health Survey (2105), 24h food recall, an Active Australia Questionnaire and Edinburgh Depression scale. Initial dietetic consultations for each of the participants is educational and advice based, and lasts for 45 approximately minutes. This is with a senior clinical dietitian with more than 10 years experience. It includes the rational for the concern over excessive gestational weight gain. It is personalised and involves information on culturally appropriate meal planning, healthy weight gain targets during pregnancy, nutritional requirements for pregnancy, strategies to limit sugar and saturated fat consumption, and how to approach non–hungry eating. Participants will be given exercise-related advice, specifically on the importance of how to incorporate 30-45min of moderate-intensity physical activity into their day. Moderate intensity means being able to hold a conversation while exercising without being short of breath, such as brisk walking, swimming or yoga/pilates. This will be provided by the dietitian and or midwife. Individualised dietary and exercise advice will be tailored by identifying gaps in the participant's dietary knowledge and exercise regimen, and optimised by providing appropriate advice to address these issues during initial and review consultations as required. Participants in the Intervention group will also receive regular monthly follow-up consultations with a midwife and dietitian until 28 weeks gestation, biweekly consultations from 28-36 weeks gestation, and weekly consultations until delivery. Review consultations are approximately 30 minutes. Should Participants not attend these consultations, they will be contacted by the Senior Clinical Dietitian or Midwife for a telephone consultation. Dietary and exercise will be review and discussed during face to face consultations or telephone interactions and once again will be tailored to the needs of the individual participant and their personal circumstances. During these consultations, participants can ask for advice, and clarify any issues with eating or exercise behaviours. Adherence to the program will be monitored via a food diary, using a 24h recall, GWG and clinic attendance. Participants will also receive fortnightly SMS messages in between face to face or telephone consultations, encouraging healthy eating and appropriate physical activity. Postpartum follow up includes a 15-30min telephone call by the dietitian at 3m postpartum, reinforcing dietary and lifestyle advice, targeting weight loss goals, and revisiting healthy eating and exercise strategies. This will culminate at 26 weeks post-partum, in participants attending WH or their Early Childhood Centres, or being telephoned for maternal and infant weight and referral to transition to Get Healthy NSW for continuity of care.

Sponsors

Women's and Newborn Health, Westmead Hospital
Lead SponsorHospital

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
No

Inclusion criteria

Age > 18y Pre-pregnancy BMI > 27.5 Gestational age between 10 and 18wk Own a smartphone with SMS capability Have internet access Have sufficient skill in the English language to read text messages

Exclusion criteria

Prior diagnosis of Gestational Diabetes Prior diagnosis of Type 1 Diabetes Patients with self- reported major health or psychiatric disorders

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026