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

Trial Summary

What is the purpose of this trial?

Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle Intervention Program (NELIP) and found that those individuals with high adherence to the program were more likely to prevent EGWG. Perhaps offering participants a choice to intervention strategies may improve adherence. The current research question is: What impact does participant choice have on adherence to the introduction of nutrition and exercise components during 3 intervention strategies offered to pregnant individuals compared to no choice and does choice maintain pregnancy health outcomes? The strategies are: Group A - introducing both the nutrition and exercise components simultaneous at baseline (12-18 weeks of pregnancy) that is followed to delivery (NELIP); Group B - introducing the nutrition component first and then at 25 weeks adding the exercise component; or Group C - starting with the exercise component first, followed with introducing the nutrition component at 25 weeks. Both Groups B and C follow the full NELIP from 25 weeks to delivery (final intervention measures will occur at 34-36 weeks gestation). Follow-up will occur at birth (6-18 hours), 2, 6 and 12 months post delivery.

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 data supports the effectiveness of the treatment Nutrition and Exercise Lifestyle Intervention Program (NELIP) for pregnancy weight gain?

Research shows that the Nutrition and Exercise Lifestyle Intervention Program (NELIP) helps prevent excessive weight gain in overweight and obese pregnant women, leading to healthier pregnancy outcomes. Studies found that women who followed the program had better control over their weight gain during pregnancy compared to those who did not adhere to it. ^{1 2 3 4 5}

Is the Nutrition and Exercise Lifestyle Intervention Program (NELIP) safe for pregnant women?

The Nutrition and Exercise Lifestyle Intervention Program (NELIP) has been studied in pregnant women and is generally considered safe. It focuses on diet and exercise to manage weight gain during pregnancy, and no significant safety concerns have been reported in the studies. ^{1 3 4 6 7}

How does the Nutrition and Exercise Lifestyle Intervention Program (NELIP) differ from other treatments for pregnancy weight gain?

NELIP is unique because it combines both nutrition and exercise interventions specifically tailored for overweight and obese pregnant women to manage pregnancy weight gain, unlike other treatments that may focus solely on nutrition or exercise. This program emphasizes adherence to specific goals, which has been shown to help prevent excessive weight gain during pregnancy. ^{1 2 3 8 9}

Research Team

Michelle F Mottola, PhD

Principal Investigator

Western University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

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

Nutrition and exercise prevent excess weight gain in overweight pregnant women. [2022]

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

Are pre-pregnancy weight fluctuations and adherence to prenatal nutrition and exercise recommendations related to excessive gestational weight gain? [2021]

3. England pubmed.ncbi.nlm.nih.gov

Lifestyle intervention on diet and exercise reduced excessive gestational weight gain in pregnant women under a randomised controlled trial. [2022]

4. United States 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. [2022]

5. Egypt pubmed.ncbi.nlm.nih.gov

Patient Attitudes toward Gestational Weight Gain and Exercise during Pregnancy. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Are Canadian women achieving a fit pregnancy? A pilot study. [2021]

7. England 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. [2020]

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

Nutrition and Exercise Strategies to Prevent Excessive Pregnancy Weight Gain: A Meta-analysis. [2020]

9. Switzerland 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. [2022]