Very-Low Energy Diet for Preconception Health

Overseen By Shannon Considine, MPH, MSW

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Anti-obesity drugs

Disqualifiers: Heart, kidney, liver, autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a very-low energy diet (VLED) can improve the health of obese women before pregnancy. The researchers aim to determine if weight loss before pregnancy leads to better outcomes for both mother and baby, such as a healthier pregnancy and reduced risk of future obesity and related diseases. Participants will either follow a very-low energy diet or receive standard care, depending on their group. Women who are obese (BMI over 30) and interested in becoming pregnant are suitable for this trial, provided they don't have certain medical conditions or infertility issues.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance maternal and child health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have recently used anti-obesity drugs or appetite suppressants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that very-low energy diets (VLEDs) can help women with obesity lose significant weight before pregnancy, which is crucial for those planning to conceive. However, safety concerns exist. Some studies suggest rapid weight loss might affect a mother's nutrition before pregnancy, potentially impacting the baby's health.

On the positive side, VLEDs are generally well-tolerated. One study found that women on a VLED lost about 11.9% of their body weight in 12 weeks, surpassing those on regular diets. This suggests VLEDs can be effective, but monitoring nutrition is essential to ensure the health of both mother and baby.

While VLEDs can aid weight loss, individuals considering this approach should consult their doctor to ensure the diet is safe and healthy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the very-low energy diet (VLED) for preconception health because it offers a unique approach compared to the standard care for obese women looking to become pregnant. Unlike typical dietary advice which often focuses on gradual lifestyle changes, VLED involves a more intensive, short-term dietary intervention designed to significantly reduce calorie intake. This approach could potentially optimize women's health before pregnancy faster and more effectively by promoting significant weight loss and improving metabolic health. By directly addressing obesity-related complications before conception, VLED may enhance fertility outcomes and reduce pregnancy-related risks.

What evidence suggests that this trial's treatments could be effective for preconception health?

Research has shown that very-low energy diets (VLEDs) can help women with obesity lose weight before attempting pregnancy. In this trial, some participants will adopt a VLED to assess its impact on preconception health. Studies have found that women who lose weight before conceiving are more likely to become pregnant. Specifically, one study discovered that women who used diet and exercise had nearly twice the pregnancy rates compared to those who did not. Additionally, women who lost weight before getting pregnant experienced an increase in live birth rates. While these diets seem promising for improving pregnancy chances, researchers continue to study their effect on live birth rates. ^{1 6 7 8 9}

Who Is on the Research Team?

Amy Rothberg, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for obese women with a BMI between 30 and 45 who want to lose weight before getting pregnant. They should not have infertility issues, significant medical conditions, or a history of certain treatments like bariatric surgery. Healthy-weight women with a BMI up to 25 can also join.

Inclusion Criteria

BMI > 30 ≤ 45 for obese participants

BMI ≤ 25 for healthy body weight participants

No known risk factors for tubal disease

Exclusion Criteria

My endometriosis is classified as severe.

Current pregnancy

Conditions that would complicate pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconception Weight Loss Intervention

Participants undergo a dietary intervention aimed at preconception weight loss, with a focus on either a very-low energy diet (VLED) or standard of care (SOC) nutrition counseling.

16 weeks

Pregnancy Monitoring

Participants are monitored throughout pregnancy with assessments of fetal growth, maternal metabolite levels, and other health indicators.

Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks)

Delivery and Immediate Postpartum

Assessment of delivery outcomes, including mode of delivery and immediate neonatal health metrics such as body fat mass and metabolome analysis.

At delivery

Infant Follow-up

Infant growth and health are monitored at regular intervals to assess long-term outcomes related to the preconception intervention.

Delivery to 12 month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Very-low energy Diet (VLED)

Trial Overview The study tests if losing weight through a Very-low energy Diet (VLED) before conception leads to better health for the mother and baby compared to standard care. It aims to see if this improves birth outcomes and reduces future obesity risks in children.

How Is the Trial Designed?

Group I: Obese - Very low energy diet (VLED) Experimental Treatment 1 Intervention

Participants will adopt a very-low energy diet

Group II: Obese - Standard of care (SOC) Experimental Treatment 1 Intervention

Participants will receive the standard of care for obese women looking to become pregnant.

Group III: Lean - Standard of care (SOC) Experimental Treatment 1 Intervention

Participants will receive the standard of care for lean women looking to become pregnant.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

This study is testing a lifestyle intervention called 'Healthy for my Baby' aimed at improving diet and lifestyle in 68 non-infertile overweight or obese women and their partners during the preconception period, using motivational interviews and a mobile app for self-monitoring.

The primary goal is to enhance women's diet quality, measured by the C-HEI 2007 score, with the potential to reduce pregnancy complications and prevent future health issues, indicating a need for larger trials if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy for My Baby Research Protocol- a Randomized Controlled Trial Assessing a Preconception Intervention to Improve the Lifestyle of Overweight Women and Their Partners. Hardy, I., Lloyd, A., Morisset, AS., et al.[2022]

Very-low-energy diets (VLEDs) combined with behavioral programs resulted in a significant weight loss of -3.9 kg at 12 months compared to behavioral programs alone, indicating their efficacy in long-term weight management.

The study found that VLEDs were generally well-tolerated, with a similar rate of treatment discontinuation compared to control groups and only one serious adverse event reported, suggesting they could be safely used more widely than current guidelines recommend.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of very-low-energy diets in the management of weight loss: a systematic review and meta-analysis of randomized controlled trials. Parretti, HM., Jebb, SA., Johns, DJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9608905/

Using a Very Low Energy Diet to Achieve Substantial ... Very low energy diets (VLEDs) have been proposed as a possible tool to assist women with obesity achieve weight loss prior to conception.

2. fertstert.org fertstert.org/article/S0015-0282(24)00126-2/fulltext

Effectiveness of preconception weight loss interventions on ... Pregnancy rates were higher in women undergoing preconception weight loss interventions with no impact on live birth or miscarriage rates.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0015028224001262

Effectiveness of preconception weight loss interventions on ... A recent meta-analysis found interventions combining diet and exercise led to higher pregnancy (RR: 1.87, CI: 95% 1.20–2.93) and live birth rates (RR: 2.20, CI: ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11384273/

Effectiveness of preconception weight loss interventions on ... Women randomized to weight loss interventions ≤ 12 weeks had a nonsignificant trend toward more live births 228/768 (29.7%) compared to the control group 192/ ...

5. academic.oup.com academic.oup.com/humrep/article/32/9/1925/3958121

Systematic review and meta-analysis of the impact of ... Primary outcomes were live birth, birth weight and pregnancy rate (both from natural conception and ART). Secondary outcomes included ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36297107/

Using a Very Low Energy Diet to Achieve Substantial ... Very low energy diets (VLEDs) have been proposed as a possible tool to assist women with obesity achieve weight loss prior to conception.

7. research.monash.edu research.monash.edu/en/publications/using-a-very-low-energy-diet-to-achieve-substantial-preconception

Using a Very Low Energy Diet to Achieve Substantial ... While VLEDs can induce substantial and rapid weight loss, there are concerns about the impact of rapid weight loss on maternal nutrition prior to pregnancy and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325001267

Dietary Patterns and Diet Quality before and/or during ... Low diet quality during periconception has been associated with adverse birth outcomes such as preterm birth and low birthweight [5,7]. Dietary interventions ...

9. researchgate.net researchgate.net/publication/346436954_Time_to_pregnancy_after_a_prepregnancy_very-low-energy_diet_program_in_women_with_obesity_substudy_of_a_randomized_controlled_trial

Time to pregnancy after a prepregnancy very-low-energy ... Result(s): Maternal weight loss at the end of the 12-week intervention was 3.1% in the SDI group and 11.9% in the VLED group. In completers of ...