Lifestyle Intervention for Preconception Care in Overweight Women

Recruiting at 1 trial location

Overseen By Ana C Colmenares, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Diabetes, Bariatric surgery, Eating disorder, others

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

Compensation: Varies

Number of Visits: 9

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program, "Healthy for my Baby," can help overweight women and their partners adopt healthier habits before pregnancy. The program includes motivational talks and a mobile app to guide lifestyle changes. Researchers seek to assess whether this approach improves weight and body measurements and affects pregnancy outcomes such as weight gain and baby birth weight. Women who plan to conceive within a year, have a body mass index (BMI) of 25 or more, and own a smartphone might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance pre-pregnancy health for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for preconception care in overweight women?

Research has shown that programs like "Healthy for my Baby" are generally safe and easy to follow. This program helps overweight women and their partners make healthier choices before pregnancy. Studies have found that similar programs can lead to better eating and more exercise without serious side effects.

Participants in these programs often see improvements in weight and waist size, indicating effectiveness without harm. No major problems have been reported with this type of program, making it a safe choice for those wanting to adopt healthier habits before pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Healthy for my Baby" intervention because it aims to address preconception care for overweight women through lifestyle changes, which is a different approach compared to standard medical treatments. Unlike typical options that might focus on medication or surgery, this intervention emphasizes healthy habits, which can be more sustainable and empowering for participants. By encouraging changes in diet, physical activity, and overall health awareness before pregnancy, this method has the potential to improve outcomes for both the mother and future child in a more holistic way.

What evidence suggests that the Healthy for my Baby Lifestyle Intervention could be effective for preconception care in overweight women?

Research shows that lifestyle changes can help overweight women improve their health before and during pregnancy. Studies have found that focusing on diet and exercise leads to better weight control and healthier habits. Early results from similar programs suggest improvements in weight, waist size, and overall body health. While results can differ, some studies show a positive effect on reducing pregnancy complications. In this trial, participants will join either the "Healthy for my Baby" program, which provides tools and support to encourage these healthy changes, or a control group receiving usual care. ^{1 2 5 6 7}

Who Is on the Research Team?

William D Fraser, MD,MSc

Principal Investigator

Researcher, Centre de recherche du CHUS

Are You a Good Fit for This Trial?

This trial is for overweight women with a BMI of ≥25 kg/m2 who plan to conceive within the next year, and their partners. They must have access to a smartphone but can't join if they have diabetes, prior weight loss surgery, or conditions affecting weight significantly. Women with infertility issues, eating disorders, or contraindications to pregnancy or exercise are also excluded.

Inclusion Criteria

My BMI is 25 or higher.

I or my partner plan to try for a baby within the next year.

Access to a smart phone

Exclusion Criteria

Medical contraindication to physical activity

I have had weight loss surgery in the past.

Insufficient knowledge of French or English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconception Intervention

Participants receive motivational interviewing sessions and use a mobile app to improve lifestyle habits

6 months

Research visits every 3 months

Pregnancy Monitoring

Participants are monitored for gestational weight gain and pregnancy outcomes

9 months

Visits in each trimester (6-8 weeks, 24-26 weeks, 32-34 weeks)

Follow-up

Participants are monitored for safety and effectiveness after pregnancy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy for my Baby
• Usual Care

Trial Overview The study tests whether motivational talks and a mobile app can help couples adopt healthier habits before pregnancy. It tracks changes in women's and partners' weight and body fat. The impact on pregnancy outcomes like complications, delivery mode, and baby's birth weight will be evaluated.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Healthy for my Baby Intervention

Group II: Control Experimental Treatment 1 Intervention

Usual care

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Published Research Related to This Trial

Only one third of obese women seek preconception care, and even fewer discuss weight-related issues during their visits, highlighting a gap in essential health education.

Obese women should be informed about the risks associated with pregnancy and encouraged to lose weight and exercise before conception to reduce potential complications, emphasizing the importance of tailored preconception counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception Care of the Obese Woman. Delcore, L., Lacoursiere, DY.[2016]

A survey of 126 women, many of whom were pregnant or planning to become pregnant, revealed that 96% believe maintaining a healthy diet and weight before pregnancy is important, highlighting a strong awareness of the need for pre-conception health.

Among overweight or obese respondents, 77% expressed interest in participating in a lifestyle program focused on diet, weight management, and physical activity, indicating a readiness to engage in interventions aimed at improving pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's attitudes towards a pre-conception healthy lifestyle programme. Funk, KL., LeBlanc, ES., Vesco, KK., et al.[2015]

In a study involving 342 obese pregnant women, those following a hypocaloric Mediterranean diet combined with physical activity significantly reduced their intake of added sugars and saturated fats, which are linked to gestational weight gain (GWG).

The research found that high consumption of sweets and snacks was strongly associated with increased GWG, suggesting that focusing on reducing these specific foods may be more effective in managing weight gain during pregnancy than adhering to strict dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of Sweets, Snacks and Soft Drinks Predicts Weight Gain in Obese Pregnant Women: Detailed Analysis of the Results of a Randomised Controlled Trial. Renault, KM., Carlsen, EM., Nørgaard, K., et al.[2018]

The Towards Prepared Mums study aims to evaluate the effectiveness of a preconception lifestyle intervention on reducing perinatal complications in 112 women with overweight or obesity, focusing on physical activity, diet, and smoking cessation, monitored until 12 months postpartum.

This randomized controlled trial will assess primary outcomes like weight change at 6 weeks postpartum, along with secondary outcomes such as gestational weight gain and postpartum weight retention, highlighting the potential benefits of early lifestyle modifications before conception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands. Timmermans, YEG., van de Kant, KDG., Reijnders, D., et al.[2020]

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]

Preconception lifestyle interventions, particularly for overweight or obese subfertile women, led to significant weight loss and an increased natural pregnancy rate, but did not improve live birth rates or birth weight.

The systematic review included eight studies with a focus on women undergoing assisted reproductive technology (ART), highlighting the need for further research on the optimal components and timing of lifestyle interventions for broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of the impact of preconception lifestyle interventions on fertility, obstetric, fetal, anthropometric and metabolic outcomes in men and women. Lan, L., Harrison, CL., Misso, M., et al.[2018]

A preconception lifestyle intervention led to a significant reduction in energy intake (by 216 kcal/day) among women with obesity and infertility, even 5.5 years after the intervention ended.

Women who successfully lost weight during the intervention maintained a lower BMI at follow-up compared to those who did not lose weight, indicating the long-term benefits of effective weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception lifestyle intervention reduces long term energy intake in women with obesity and infertility: a randomised controlled trial. van Elten, TM., Karsten, MDA., Geelen, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8369366/

Healthy for My Baby Research Protocol This study will evaluate the effectiveness of a low-cost intervention designed to improve diet and other lifestyle characteristics of women in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04242069

Healthy for my Baby- RCT of a Lifestyle Intervention ... Secondary outcomes for preconception include the effect of the intervention on the lifestyle habits and anthropometric measures of women and their partners. In ...

3. researchgate.net researchgate.net/publication/353689190_Healthy_for_My_Baby_Research_Protocol-_a_Randomized_Controlled_Trial_Assessing_a_Preconception_Intervention_to_Improve_the_Lifestyle_of_Overweight_Women_and_Their_Partners

a Randomized Controlled Trial Assessing a Preconception ... Discussion: This study will evaluate the effectiveness of a low-cost intervention designed to improve diet and other lifestyle characteristics ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12530384/

Pre-conception lifestyle intervention to optimise maternal ... Our aim is to conduct a randomised controlled trial of a comprehensive lifestyle intervention for women with overweight or obesity who are ...

5. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(23)00103-1/fulltext

Why do preconception and pregnancy lifestyle ... Results from systematic reviews of preconception and pregnancy lifestyle interventions have shown mixed success in improving children's weight outcomes and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34414154/

Healthy for My Baby Research Protocol This study will evaluate the effectiveness of a low-cost intervention designed to improve diet and other lifestyle characteristics of women in the ...

7. nature.com nature.com/articles/s41598-022-06564-2

Developing a lifestyle intervention program for overweight ... Lifestyle interventions for overweight and obese pregnant women to improve pregnancy outcome: systematic review and meta-analysis. BMC Med ...