PRE-BABE: Pre-conception weight loss for women above a healthy weight: a pilot randomized controlled trial
Feasibility and acceptability of an online pre-conception weight loss program for women with overweight and obesity? A pilot randomised controlled trial
Impromy
50 participants
Jun 14, 2018
Interventional
Conditions
Summary
BACKGROUND: High preconception BMI is the single most important modifiable risk factor for adverse perinatal outcomes and offspring obesity. Trials to limit weight gain during pregnancy have not lived up to the promise of reducing this burden. There is increasing recognition that targeting obesity before pregnancy might improve outcomes for mother and baby. However, there are no current guidelines to suggest which preconception health programs and interventions are of benefit to women above a healthy weight and their infants. Thus, there is urgent need to establish the effectiveness of preconception weight loss, in order to improving short and long-term maternal and child health. AIM: To assess the feasibility and acceptability of a 10 week online weight loss program in women with a BMI >25 kg/m2 who are planning pregnancy. Intervention: Women will be randomly allocated to one of the following programs for 10 weeks: 1. An online weight loss program 2. Recommended weight loss advice delivered in a clinic setting RECRUITMENT: recruitment will occur over the next 6 months. Eligible women will be recruited from the RPA pregnancy planning clinic, Charles Perkins Centre. OUTCOMES: Weight loss: Measured in kilograms at 10 weeks
Eligibility
Inclusion Criteria5
- – Women with a BMI greater than or equal to 25kg/m2;
- – Aged >/= 18 - 40 years;
- – Willing to attend CPA RPA clinic on 3 occasions;
- – Willing to follow a weight loss dietary protocol for 10 weeks
- – Has been weight stable (i.e. less than 3 kg weight loss) for the past 2 months.
Exclusion Criteria8
- – Significant pre-existing, diagnosed medical condition that may prevent them from participating in the study, including but not limited to: Kidney disease or renal impairment; Gall bladder disorders or stones; Liver disease (e.g. cirrhosis); severe cardiovascular disease where rapid weight loss is contraindicated eg Cardiac arrhythmia, congenital heart disease; Malabsorptive Gastrointestinal disease (including celiac, Crohns disease);
- – History of bariatric surgery;
- – Severe depression;
- – Cancer (unless benign or non-progressive skin cancer);
- – Type 1 or type 2 diabetes.
- – Regular use of medications prescribed by a medical practitioner that are deemed unsuitable for this trial – as determined by the appointed study physician during screening process;
- – A food allergy/intolerance to, or not willing to consume, the foods prescribed in the protocol;
- – A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol;
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Interventions
The aim of this trial is to compare the effects of a partial meal replacement diet (Flexi) vs recommended advice both delivered in a clinic setting on pre-conception weight loss, in women with a BMI>25kg/m2 planning a pregnancy within the next 6 to 12 months. The intervention arm comprises an Australian meal replacement product (details available on the website https://www.impromy.com/flexi-by-impromy/) that will be delivered in a clinic setting targeted for women planning pregnancy. All women will have a baseline and a 5 and 10 week appointment with a dietitian. The baseline and the 10 week appointments last 1 hour and the 5 week appointment 30 minutes. Women randomised to the intervention arm will be advised to follow the Flexi program for 10 weeks and will receive advice on how to log on plus be given their meal replacements in the clinic. The Flexi program is based on alternate day energy restriction (eg Tuesday, Thursday, and Sunday comprise meal replacements and one healthy meal with protein and Monday, Wednesday, and Friday meal replacements plus salad/vegetables) to allow for one day per week to eat ad libitum ( eg Saturday). A trained research dietitian will deliver and monitor the dietary intervention. Individual estimated energy requirements will be calculated for all women at study visit 1 based on actual body weight, multiplied by appropriate physical activity levels and reduced by 25-30% to achieve energy restriction for weight loss. This individualized energy level determines the number of formulated meal replacements and the number of snacks for each woman. As an example women with BMI 25 - 30 are likely to require 2 meal replacements per day and BMI > 30 3 meal replacements per day. Meal replacements require reconstitution with 250 mL of either skim milk or a dairy-free alternative (unsweetened, calcium-enriched). The 10-week meal replacement diet program selected for this trial uses nutritionally complete meal replacement products. (ImpromyTM, manufactured by Probiotec Pty Ltd., Laverton North, Australia; MR =~1000kJ, 25g protein, 4g fat, 27g carbohydrate, 6g fibre with each containing 25% recommended daily intake for Vitamin A, Thiamin, Riboflavin, Niacin, Folate, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Calcium, Iodine, Iron, Magnesium, Phosphorus and Zinc.) The total daily macronutrient distribution for the MRP diet shown above was 31% of total energy as carbohydrate, 38% protein and 28% total fat (52% monounsaturated fat and 17% polyunsaturated fat) with the remaining 3% non-soluble fibre. Prescribed snack option for the plan include: fruit, low fat dairy, wholegrains and nut/seed/legume. The number of snacks allocated per day is also tailored to individual energy requirements for weight loss. Behavioural strategies included in the dietitian visits and the accompanying website include, goal setting, self-monitoring of behaviour and progress, stimulus control (e.g. recognising triggers that prompt unplanned eating), cognitive restructuring (modifying unhelpful thoughts), problem solving, assertiveness, slowing the rate of eating, reinforcing changes and relapse prevention. We will also provide a helpline for the program so women are able to access a dietitian for advice during the 10 weeks. This support will be available via a dedicated email monitored by 3 study team members and a study mobile phone during business hours. The website provides general advice regarding the program and weight loss support plus a virtual consultation which has been informed through the FAQs of the CSIRO pilot trial and has been designed by dietitians Women will also receive a copy of the printed booklet from the Australian Government website regarding healthy weight. http://healthyweight.health.gov.au We will monitor adherence to the meal replacements by questionnaires, weight measurement at the study visit and a count of supplied products to the participating women
Locations(1)
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ACTRN12620000597998