Nutrition and Exercise for Pregnancy Weight Gain

(NELIP Trial)

Overseen By Edit Somogyi, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Inability to walk, serious medical problems, high blood pressure, diabetes, others

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

Compensation: Varies

Number of Visits: 4

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether offering pregnant individuals a choice in nutrition and exercise plans can improve adherence and support healthy weight gain during pregnancy. Participants can select from three strategies: starting both nutrition and exercise early, beginning with nutrition and adding exercise later, or starting with exercise and adding nutrition later. The trial seeks pregnant individuals between 12 to 18 weeks along with a single baby, who can safely engage in exercise. As an unphased trial, this study provides participants the chance to contribute to valuable research that may enhance prenatal health strategies.

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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Nutrition and Exercise Lifestyle Intervention Program (NELIP) is safe for pregnant individuals?

Research has shown that the Nutrition and Exercise Lifestyle Intervention Program (NELIP) is generally safe for pregnant women. Studies have found that this program can help control weight gain during pregnancy without causing harm. For example, one study found that 80% of women in the program did not gain excessive weight. Another study demonstrated that the program prevented excessive weight gain without causing insufficient weight gain. These findings suggest that NELIP is well-tolerated and supports healthy pregnancy outcomes. Overall, the program emphasizes diet and exercise, which are safe and beneficial for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Exercise Lifestyle Intervention Program for managing pregnancy weight gain because it offers a personalized approach. Unlike standard care options that might focus solely on general dietary guidelines or exercise without integration, this program allows participants to choose how they want to combine nutrition and exercise, tailoring the intervention to their preferences. Additionally, the flexibility of sequential or simultaneous implementation of nutrition and exercise components is a novel approach that could enhance adherence and effectiveness. This trial could provide valuable insights into the best ways to manage weight gain during pregnancy by aligning treatment with individual preferences and needs.

What evidence suggests that this trial's interventions could be effective for preventing excessive gestational weight gain?

The Nutrition and Exercise Lifestyle Intervention Program (NELIP) is under study in this trial to help prevent excessive weight gain during pregnancy. Participants will either choose from three strategies or be matched with a participant who has a choice. Studies have shown that NELIP can be effective; specifically, 80% of women in one study did not gain more weight than recommended. Another study found that women in the NELIP program gained an average of 12 kg during pregnancy, which is considered healthy. This program combines healthy eating and exercise, proven to manage weight effectively without causing unhealthy weight loss. Overall, NELIP has successfully helped pregnant women maintain a healthy weight. ^{1 2 3 6 7}

Who Is on the Research Team?

Michelle F Mottola, PhD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals interested in managing weight gain through a healthy lifestyle. Participants should be willing to adhere to a nutrition and exercise program, with no major health issues that would limit their ability to follow the intervention.

Inclusion Criteria

Medically screened with the Get Active Questionnaire for Pregnancy to determine eligibility for participation in the exercise component

I am 12 to 18 weeks pregnant with one baby.

Exclusion Criteria

Any contraindication to exercise

I cannot walk.

Enrolled in another clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants follow one of three strategies involving nutrition and exercise components from 12-18 weeks of pregnancy to delivery

22-24 weeks

Weekly monitoring

Follow-up

Participants and infants are monitored for health outcomes at birth and at 2, 6, and 12 months post-delivery

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nutrition and Exercise Lifestyle Intervention Program

Trial Overview The study tests how giving participants a choice affects adherence to a lifestyle program aimed at preventing excessive weight gain during pregnancy. It compares three strategies: simultaneous nutrition and exercise introduction, staggered introduction of each component, or following an established full program from mid-pregnancy.

How Is the Trial Designed?

Group I: No choice Experimental Treatment 1 Intervention

Participants will be yoked (matched) to a participant in the Choice group and they receive the same strategy as the person with a choice.

Group II: Choice Active Control 1 Intervention

Participants will be given a choice of 3 strategies; Group A - they receive both nutrition and exercise components simultaneously, Group B - they receive the nutrition component first followed by introduction of the exercise component sequentially, or Group C - they receive the exercise component first followed by introduction of the nutrition component sequentially.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

A survey of 182 pregnant women revealed that while most received counseling on weight gain and exercise, a significant portion (28% of obese women) did not receive exercise counseling, highlighting a gap in support for maintaining physical activity during pregnancy.

Despite the benefits of exercise, many women reduced their exercise frequency during pregnancy, with 40.6% exercising three or more days a week before pregnancy compared to only 30.7% during pregnancy, indicating a need for better encouragement and resources to promote physical activity among expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Attitudes toward Gestational Weight Gain and Exercise during Pregnancy. Lott, ML., Power, ML., Reed, EG., et al.[2020]

In a study of 81 pregnant women, most were not meeting the recommended guidelines for physical activity (PA) and gestational weight gain (GWG), despite receiving advice from healthcare providers, with many classified as sedentary.

Women who engaged in more than 8.5 MET-hours of physical activity per week were more likely to achieve appropriate weight gain during pregnancy, highlighting the need for clearer PA guidelines for expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Canadian women achieving a fit pregnancy? A pilot study. Cohen, TR., Plourde, H., Koski, KG.[2021]

The Nutrition and Exercise Lifestyle Intervention Program (NELIP) helped overweight and obese pregnant women gain less weight during pregnancy, with an average total weight gain of 12.0 kg, and 80% of participants did not exceed recommended weight gain limits.

At 2 months postpartum, women on the NELIP retained only 2.2 kg of weight, indicating that the program may effectively support weight control after childbirth without negatively impacting birth weight, which was similar to that of a matched historical cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and exercise prevent excess weight gain in overweight pregnant women. Mottola, MF., Giroux, I., Gratton, R., et al.[2022]

Nutrition-only interventions significantly reduce gestational weight gain (GWG) compared to routine prenatal care, making them the most effective strategy for staying within the recommended guidelines, based on a review of 31 studies involving 8,558 participants.

While exercise-only and nutrition-plus-exercise interventions showed trends toward reducing GWG, they did not reach statistical significance, indicating that focusing on nutrition may be the most impactful approach, especially for overweight or obese women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and Exercise Strategies to Prevent Excessive Pregnancy Weight Gain: A Meta-analysis. Craemer, KA., Sampene, E., Safdar, N., et al.[2020]

A diet and exercise intervention for 90 pregnant women significantly reduced total gestational weight gain and weekly weight gain compared to a control group, indicating effective weight management during pregnancy.

The intervention also led to lower postpartum weight retention and optimized infant birth weight, suggesting that lifestyle changes can positively impact both maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of diet and exercise intervention in Chinese pregnant women on gestational weight gain and perinatal outcomes: A quasi-experimental study. Liu, YQ., Liu, Y., Hua, Y., et al.[2022]

A lifestyle intervention that included exercise and dietary counseling significantly reduced excessive gestational weight gain (EGWG) among 190 pregnant women, with the intervention group showing better outcomes than the control group.

Participants in the intervention group not only decreased their calorie and fat intake but also increased their physical activity levels, indicating that such interventions can effectively improve health behaviors during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention on diet and exercise reduced excessive gestational weight gain in pregnant women under a randomised controlled trial. Hui, A., Back, L., Ludwig, S., et al.[2022]

The structured nutrition and exercise program improved dietary quality and protein intake in pregnant women, but did not significantly affect gestational weight gain (GWG) compared to usual care, with both groups showing similar pregnancy outcomes.

Although the intervention group was more likely to achieve GWG within recommended guidelines, the exercise goal of 10,000 steps per day was not met, averaging only 6335 steps per day, indicating a need for more achievable physical activity targets in pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Be Healthy in Pregnancy (BHIP): A Randomized Controlled Trial of Nutrition and Exercise Intervention from Early Pregnancy to Achieve Recommended Gestational Weight Gain. Atkinson, SA., Maran, A., Dempsey, K., et al.[2022]

A systematic review identified five dietary and lifestyle interventions during pregnancy that are beneficial or possibly beneficial in reducing risk factors for childhood obesity, including balanced energy/protein supplements and dietary counseling.

High protein supplementation was found to be harmful, increasing the risk of small-for-gestational age infants in normal-weight pregnant women, highlighting the importance of careful dietary choices during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Life Trajectories Initiative: Summary of the evidence base for pregnancy-related interventions to prevent overweight and obesity in children. Grobler, L., Visser, M., Siegfried, N.[2020]

In a study of 100 women with a pre-pregnancy BMI of 25.0 kg/m² or higher, those who gained excessive weight during pregnancy were more likely to have attempted weight loss before conception, with 61% reporting such efforts compared to 39% of those who did not gain excessively.

Women who gained excessive weight had lower adherence to nutrition and exercise recommendations from the Nutrition and Exercise Lifestyle Intervention Program, scoring an average of 3.3 out of 6 goals, which was significantly less than the 4.4 average score of those who did not gain excessively, indicating that better adherence may help manage gestational weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are pre-pregnancy weight fluctuations and adherence to prenatal nutrition and exercise recommendations related to excessive gestational weight gain? Nagpal, TS., Prapavessis, H., Campbell, CG., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2886034/

Nutrition and Exercise Prevent Excess Weight Gain in ... Excessive weight gain occurred before NELIP began at 16 wk of gestation. Eighty percent of the women did not exceed recommended pregnancy weight gain on NELIP.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20083959/

Nutrition and exercise prevent excess weight gain in ... Results: Weight gained by women on the NELIP was 6.8 +/- 4.1 kg (0.38 +/- 0.2 kg x wk(-1)), with a total pregnancy weight gain of 12.0 +/- 5.7 kg. Excessive ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02804061

Early Prevention of Excessive Gestational Weight Gain ... The Nutrition and Exercise Lifestyle Intervention Program (NELIP) is a previously published two-behaviour change program which was successful in preventing EGWG ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/1471-2393-13-151

Safety and efficacy of a lifestyle intervention for pregnant ... Lifestyle counseling given to pregnant women reduced the proportion of pregnancies with excessive GWG without increasing suboptimal weight gain, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01693666

Lifestyle Intervention Forever: Healthy Weight for ... The ultimate goal of this research is to examine the impact of a healthy lifestyle intervention, targeting weight gain restriction during pregnancy in obese ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00486629?tab=table

Impact of Diet and Exercise Activity on Pregnancy Outcomes Lifestyle intervention on diet and exercise reduced excessive gestational weight gain in pregnant women under a randomized controlled trial. Br J Obstetr ...

7. withpower.com withpower.com/trial/phase-pregnancy-related-2024-be5c0

Nutrition and Exercise for Pregnancy Weight Gain The Nutrition and Exercise Lifestyle Intervention Program (NELIP) has been studied in pregnant women and is generally considered safe. It focuses on diet and ...