Lifestyle Intervention for Preconception Care in Overweight Women

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by William D Fraser, MD,MSc

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Université de Sherbrooke

Disqualifiers: Diabetes, Bariatric surgery, Eating disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether an intervention combining motivational interviewing and follow-up with a mobile phone application will help overweight women and their partners adopt healthy lifestyle habits in the preconception period. This study will also evaluate the impact of the intervention on the weight, waist circumference, and body fat of women and their partners. Women and their partners will be followed through pregnancy to explore the effects of the intervention on the adequacy of gestational weight gain, rates of pregnancy complications, delivery mode, and infant birth weight.

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 data supports the effectiveness of the treatment Healthy for my Baby Lifestyle Intervention for preconception care in overweight women?

Research suggests that preconception lifestyle interventions can help improve diet quality and reduce weight gain during pregnancy, which may lead to better pregnancy outcomes. Women are generally positive about participating in such programs, indicating a strong interest in improving their health before pregnancy. ^{1 2 3 4 5}

Is the preconception lifestyle intervention safe for overweight women?

The available research does not specifically address safety concerns, but preconception lifestyle interventions generally focus on improving diet and physical activity, which are typically safe and beneficial for overall health. ^{1 3 4 5 6}

How is the Healthy for my Baby treatment different from other treatments for overweight women before pregnancy?

The Healthy for my Baby treatment is unique because it focuses on improving lifestyle habits, such as diet and physical activity, in overweight women and their partners before pregnancy, using motivational interviews and a mobile app for self-monitoring. This approach is different from other treatments that typically address weight issues during pregnancy rather than before conception. ^{1 2 3 4 7}

Research Team

William D Fraser, MD,MSc

Principal Investigator

Researcher, Centre de recherche du CHUS

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Healthy for my Baby (Behavioral Intervention)
• 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.

Participant Groups

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+

Pierre Cossette

Université de Sherbrooke

Chief Executive Officer since 2017

MD from Université de Sherbrooke

Denyse Rémillard

Université de Sherbrooke

Chief Medical Officer since 2023

MD from Université de Sherbrooke

Findings from Research

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]

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]

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 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]

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]

References

1. Switzerland 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. [2022]

2. United States 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. [2018]

3. England 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. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Women's attitudes towards a pre-conception healthy lifestyle programme. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Preconception lifestyle intervention reduces long term energy intake in women with obesity and infertility: a randomised controlled trial. [2020]

6. England 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Preconception Care of the Obese Woman. [2016]