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Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial.

Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000161426
Acronym
LIMIT
Enrollment
2212
Registered
2007-03-09
Start date
2008-05-28
Completion date
2012-02-08
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

AIMS OF THE RESEARCH Being overweight or obese is a major health issue for Australian women during pregnancy and childbirth. There are well documented risks associated with obesity during pregnancy, including for the mother high blood pressure, diabetes and caesarean section. Babies of mothers who are overweight or obese are more likely to be large for gestational age, need admission to the nursery and to require treatment for jaundice and low blood sugar levels. This randomised trial will assess whether implementing a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit weight gain is effective in improving maternal, fetal and infant health outcomes. EXPECTED OUTCOMES OF THE RESEARCH If dietary and lifestyle advice is effective this would be a highly beneficial and cost effective treatment to redice the burden of disease to mothers and their infants caused by obesity.

Interventions

Women randomised to the Dietary and Lifestyle Advice Group will receive a comprehensive intervention to limit weight gain in pregnancy that includes a combination of dietary, exercise and behavioural strategies, delivered by a research dietician and trained research assistants. Women will be provided with dietary advice consistent with current Australian dietary standards, that maintains a balance of carbohydrates, fat and protein. Women will be encouraged to reduce their intake of foods high in

Women randomised to the Dietary and Lifestyle Advice Group will receive a comprehensive intervention to limit weight gain in pregnancy that includes a combination of dietary, exercise and behavioural strategies, delivered by a research dietician and trained research assistants. Women will be provided with dietary advice consistent with current Australian dietary standards, that maintains a balance of carbohydrates, fat and protein. Women will be encouraged to reduce their intake of foods high in refined carbohydrates and saturated fats, while increasing their intake of fibre, and promoting consumption of two serves of fruit and five serves of vegetables each day. Exercise advice will focus on encouraging women to adopt a more active lifestyle, primarily by increasing the amount of walking. Tailoring of the intervention will be informed by stage theories of health decision making that propose that individuals progress through a series of cognitive phases when undertaking behavioural change. Initially, there will be a 1 hour planning session with a research dietician, in which women are provided with written dietary and activity information, an individual diet and physical activity plan, a food and activity diary, recipe book and example menu plans. Women will be encouraged to set achievable goals for dietary and exercise change, supported to make these lifestyle changes and to self-monitor their progress. Additionally, women will be encouraged to identify potential barriers and enablers to facilitate the implementation of their goals. This information will be reinforced during subsequent inputs at regular intervals during pregnancy, provided by the research dietician (at 28 weeks’ gestation) and trained research assistants (via telephone call at 22, 24, and 32 weeks’ gestation and a face-face visit at 36 weeks’ gestation).

Sponsors

Women's and Children's Hospital, Adelaide, SA.
Lead SponsorHospital

Study design

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

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Pregnant women with a singleton, live gestation between 10+0 - 20 weeks who are obese or overweight (defined as a body mass index greater that 25kg/m2).

Exclusion criteria

Women with multiple pregnancy, or type 1 or type 2 diabetes diagnosed prior to pregnancy.There is no age range criteria for this trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 28, 2026