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Pregnancy Outcomes after Pre-pregnancy weight loss in obese women (POP Study)

Does substantial pre-conception weight loss, achieved using a 12-week program of a Very Low Energy Diet, improve pregnancy outcomes compared to modest weight loss achieved using a diet and exercise program in obese women?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001160628
Acronym
POP Study
Enrollment
164
Registered
2014-11-04
Start date
2014-11-05
Completion date
2018-02-10
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

This is a two arm parallel group randomised controlled trial to determine if substantial weight loss is superior to modest weight loss in reducing maternal glucose at 26-28 weeks gestation and therefore preventing adverse maternal and neonatal pregnancy outcomes.

Interventions

12 week program which consists of: 1) Optifast meal replacement for 2 meals per day. The third meal consisting of a serve of protein (meat, chicken, egg, tofu approximately the size of the palm of the hand), 2 cups of non-starch vegetables and a salad dressed with oil. Patients will meet with a dietician at the start of the study for 30 minutes to discuss implementation of the diet. They will then prepare meals themselves. Participants will be seen every 2 weeks during the intervention phase. B

12 week program which consists of: 1) Optifast meal replacement for 2 meals per day. The third meal consisting of a serve of protein (meat, chicken, egg, tofu approximately the size of the palm of the hand), 2 cups of non-starch vegetables and a salad dressed with oil. Patients will meet with a dietician at the start of the study for 30 minutes to discuss implementation of the diet. They will then prepare meals themselves. Participants will be seen every 2 weeks during the intervention phase. Blood pressure, weight, waist circumference and hip circumference will be measured. 2)Exercise according to national guidelines. Patients will be asked to complete the 'Australia Active Survey' prior to commencing the study. They will then be provided with an information booklet "Australia's Physical Activity and Sedentary Behaviour Guidelines for Adults". These guidelines recommend accumulating 150 to 300 minutes (2 ½ to 5 hours) of moderate intensity physical activity or 75 to 150 minutes (1 ¼ to 2 ½ hours) of vigorous intensity physical activity, or an equivalent combination of both moderate and vigorous activities each week. Subjects will be provided with a Pedometer (Yamax 700S). Daily step count will be recorded for 7 consecutive days (week 2 of study). This is for the purposes of ensuring there is not a significant difference in activity level between our two study groups. 3) Pre-pregnancy vitamin supplement including high dose folate. Folate 5mg orally, by mouth daily is recommended in accordance with the RANZCOG 'Obesity in Pregnancy' guidelines. In addition, participants will be asked to take a multi-vitamin suitable for a woman planning pregnancy (eg. Elevit). Blood tests will be performed at the start and end of the intervention period. A food diary will be performed to ensure compliance with the diet. However, the amount of weight on on Optifast should be approximately 10-15% of body weight in 12 weeks based on the results of previous trials. *Optifast products vary slightly but an example of the components of an Optifast product are listed below. Optifast products include soups, bars, desserts, shakes. INGREDIENTS Fructose glucose syrup (sugar beet), Soy crisp (Soy protein isolate, tapioca starch, salt), Milk chocolate (17%) [Sugar, Cocoa solids (6.5%), whole Milk powder, Emulsifier (Soy lecithin), Flavour], Soy nuts, Soy protein isolate, Minerals (Tripotassium citrate, Calcium phosphate, Sodium phosphate, Magnesium phosphate, Trisodium citrate, Magnesium carbonate, Ferric pyrophosphate, Potassium iodate, Zinc oxide, Sodium selenate, Copper sulphate, Manganese sulphate), Inulin, Fruit preparation [ Sugar, Raspberry (0.6%), Apple puree (0.4%),Raspberry (0.6%) and Cherry (0.2%) juice concentrate, Fructose syrup, Lactose (9%) (Milk), Vegetable fat, Flavour, Vegetable gum (440), Food acid (330)], Vegetable oil (Rapeseed), Vitamins (Ascorbic acid, Vitamin E acetate, Nicotinamide, Biotin, Vitamin A acetate, Calcium pantothenate, Folic acid, Cholecalciferol, Pyridoxine, Riboflavin, Thiamin, Cyanocobalamin), Food acid (330), Flavour, Emulsifier (Soy lecithin). Contains Milk and Soy. Made on equipment that also processes products containing tree nuts, peanuts and oats. NUTRITIONAL INFORMATION Servings per package 6 Serving size 60g Unit of measure Quantity per serve Energy kJ 950 Cal 228 Protein g 18.3 Fat, total g 6.9 - Saturated fat g 2.6 Carbohydrates g 20.8 - Sugar g 19.3 Dietary fibre g 4.5 VITAMINS Thiamin mg 0.69 Riboflavin mg 1.02 Niacin mgNE 9.6 Pantothenic acid mg 1.9 Vit B6 mg 1 Biotin microgram 67 Folic Acid microgram 126 Vit C mg 63 Vit E mgTE 6 MINERALS Sodium mg 390 Calcium mg 270 Copper mg 0.9 Iodine microgram 66 Iron mg 9.1 Magnesium mg 150 Manganese mg 0.70 Phosphorus mg 588 Selenium microgram 36 Zinc mg 5.4 Potassium mg 732

Sponsors

University of Melbourne
Lead SponsorUniversity

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 38 Years
Healthy volunteers
No

Inclusion criteria

Planning pregnancy in the next 6 months BMI equal or greater than 30 and equal or less than 55kg/m2 Living in Victoria Australia

Exclusion criteria

Type 2 Diabetes Type 1 Diabetes Discretion of investigator Physical or psychiatric illness that would preclude the use of Optifast Currently pregnant or lactating Currently undergoing reproductive technology treatment Irreversible infertility BMI <30kg/m2 or >55kg/m2 Age <18 years old or >38 years old Not living in Victoria Australia Not planning pregnancy in the next 6-12 months (regardless of the method of conception)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026