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The PLAN Project: Pregnancy Lifestyle Activity and Nutrition: effectiveness of maternal lifestyle intervention commenced before 10 weeks gestation, in normal, overweight and obese mothers on maternal behaviours and infant's adiposity.

A randomised controlled trial investigating whether a maternal lifestyle intervention with behaviour change intervention commencing before 10 weeks gestation and consolidation phase to end of pregnancy, compared to usual clinical care, optimizes maternal lifestyle behaviour and reduces offspring adiposity.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000725369
Acronym
PLAN Project
Enrollment
57
Registered
2017-05-18
Start date
2015-12-15
Completion date
2017-04-06
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

This RCT will test whether a lifestyle intervention in early pregnancy optimizes gestational weight gain and reduces offspring adiposity. The intervention will use smart phone web based applications to deliver diet, physical activity and well being advice to overweight or obese pregnant women in early pregnancy (commenced prior t0 10 weeks gestation) to optimise their gestational weight gain (weight gain during the course of the pregnancy) within the recommended medical guidelines. The project will then follow up to assess neonatal and infant outcomes in relation to fat percentage and anthropometry.

Interventions

The Pregnancy Lifestyle Activity Nutrition (PLAN) intervention is a 12-week program in early gestation, starting before 10 weeks gestation, which includes a web based application with a weight tracker, diet, physical activity and psychological modules. Accompanying the web-based programme, participants will have access to a one on one session with a dietitian/research nurse, and follow up with personalised, automated SMS follow up on SMART goal. SMART stands for Specific Measurable Attainable Re

The Pregnancy Lifestyle Activity Nutrition (PLAN) intervention is a 12-week program in early gestation, starting before 10 weeks gestation, which includes a web based application with a weight tracker, diet, physical activity and psychological modules. Accompanying the web-based programme, participants will have access to a one on one session with a dietitian/research nurse, and follow up with personalised, automated SMS follow up on SMART goal. SMART stands for Specific Measurable Attainable Realistic Time-Based. The SMART goal is decided on in consultation with the dietician. Following the end of the 12 week intervention period, the individual continues to have access to the web-site App and SMS SMART goal follow up until the end of pregnancy. In further detail, the intervention includes: 1. Delivery of gestational weight gain guidelines according to the Institute of Medicine (The web-based application customised for this study provides a real-time feedback of a mother’s weight synchronized to her stage of pregnancy. It plots the individual’s weight against an individualized optimal weight gain based on guidelines. Immediate feedback is given when weight is entered. According to level of adherence to guidelines, escalating support will be given in the form of SMS reminders, telephone or face to face visits); 2. Web based delivery of Dietary education (on low glycemic index, low saturated fat, increased omega-3 fatty acid, increased fibre), cognitive behavioural materials to encourage goal setting, self-monitoring and problem solving and physical activity guidelines; 3. One private session with a trained research assistant who will deliver tailored feedback on dietary intake and accelerometry with personalized diet and exercise plans, and SMART goal setting. (This occurs at approximately week 2 of the intervention and the duration is approximately 45-60 minutes.) 4. Automated follow SMS targeted to the individual’s SMART goal stipulated in the one on one session. The web based intervention provides a combination of written material and interactive activities such as quizzes. The participants are progressively given access to the material with 3 modules delivered every week. Participants are given email reminders to enter weight twice a week and also emails to inform them that new modules are available. Strategies to monitor adherence will include evidence of frequency of weight logging on the web based application.

Sponsors

Telethon Kids Institute
Lead SponsorCharities/Societies/Foundations

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 who are recruited at <10 weeks gestation and have a pre-pregnancy BMI of >20, or BMI >18 in high-risk ethnic groups.

Exclusion criteria

Women with a current diagnosis of a serious pre-existing medical condition (e.g. type 1 or 2 diabetes, psychosis, eating disorder, thyroid condition or on medication for Polycystic Ovarian Syndrome) Multiple births

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 18, 2026