Time-Restricted Eating for Postpartum Weight Loss

(Time4Mom Trial)

Overseen By Camille S Worthington, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Weight loss drugs

Disqualifiers: Diabetes, Psychiatric disorders, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method called early Time-Restricted Eating (eTRE) to help new mothers with overweight or obesity lose weight after childbirth. Participants eat all meals within a 9-hour window each day, followed by a 15-hour fasting period, and receive support through remote sessions. Mothers who are 6 to 16 weeks postpartum, had a single healthy pregnancy, and have a BMI of 25 or more may qualify. The trial aims to determine if this approach is feasible and acceptable for new mothers. As an unphased study, it offers a unique opportunity to explore a new weight loss method tailored for new mothers.

Will I have to stop taking my current medications?

The trial requires that you do not use any medication expected to significantly impact body weight.

What prior data suggests that this time-restricted eating intervention is safe for postpartum women?

Research shows that early time-restricted eating (eTRE) is generally safe and easy for most people to follow. In studies with groups not specifically including new mothers, this eating pattern has led to noticeable health benefits, such as improved blood pressure and mood. For instance, one study found that eTRE helped people lose weight and lowered their diastolic blood pressure (the bottom number in a blood pressure reading). Another study found that eTRE stabilized blood sugar levels, which benefits overall health.

Although these studies did not specifically focus on new mothers, the consistent positive results suggest that eTRE is safe for most people, including those who have recently given birth. The studies reviewed have reported no serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for postpartum weight loss because it introduces a novel approach to weight management. Unlike traditional methods like calorie counting or intensive exercise routines, this technique focuses on when you eat rather than what or how much you consume. The early time-restricted eating (eTRE) method specifically involves a 9-hour eating window followed by a 15-hour fasting period, which is thought to align better with the body's natural circadian rhythms. This could potentially result in more effective weight loss and improved metabolic health for new mothers, making it a promising avenue for postpartum weight management.

What evidence suggests that early time-restricted eating is effective for postpartum weight loss?

This trial will compare early time-restricted eating (eTRE) with a control condition for postpartum weight loss. Research has shown that eating within a shorter time frame earlier in the day, known as eTRE, can aid weight loss. People tend to lose more weight with eTRE compared to eating over longer periods, such as 12 hours or more. It also appears to lower blood pressure and improve mood. Many studies suggest that eTRE helps people eat less and aligns eating times with the body's natural clock. These benefits have been observed in various groups, but more research is needed specifically for postpartum women. ^{1 3 6 7 8}

Who Is on the Research Team?

Camille S Worthington, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for postpartum women who are dealing with overweight or obesity. It's designed to see if eating during a specific time frame each day can help with weight loss after having a baby.

Inclusion Criteria

Experienced a healthy singleton pregnancy

I gave birth 6 to 16 weeks ago.

Willing to consent

Exclusion Criteria

Current substance abuse

Participation in another dietary and/or weight management intervention postpartum

I am taking medication that could majorly affect my weight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a 9-hour eating/15-hour fasting time-restricted eating intervention or a control group for 12 weeks

12 weeks

Remote behavioral support sessions

Follow-up

Participants are monitored for changes in clinical outcomes and patient-reported outcomes

10 weeks

In-person or remote interviews

What Are the Treatments Tested in This Trial?

Interventions

• Early Time-Restricted Eating (eTRE)

Trial Overview The study is testing an Early Time-Restricted Eating (eTRE) method against a control group to evaluate its effectiveness in helping postpartum women lose weight.

How Is the Trial Designed?

Group I: eTRE Intervention Experimental Treatment 1 Intervention

A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.

Group II: Control Active Control 1 Intervention

Control condition in which participants are instructed to maintain their baseline eating window with tapered remote behavioral support check-ins delivered by a trained interventionist to encourage maintenance of the baseline eating window.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study involving overweight and obese young adults, both early time-restricted eating (eTRE) and late time-restricted eating (lTRE) resulted in similar weight loss after 8 weeks compared to a control group.

eTRE was more effective than lTRE in improving several metabolic health markers, including reducing systolic blood pressure, glucose levels, fasting insulin, insulin resistance, and thyroid axis activity, while lTRE only reduced leptin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial for time-restricted eating in overweight and obese young adults. Zhang, LM., Liu, Z., Wang, JQ., et al.[2022]

A survey of 213 families attending pediatric weight management programs found that 66% of parents were interested in trying time-limited eating (TLE) for 12 hours a day, indicating a strong acceptability of this dietary approach among families.

Interest in TLE decreased significantly when the eating window was limited to 10 hours (39%) or 8 hours (26%), suggesting that flexibility in the eating schedule may enhance adherence to dietary interventions for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of Time-Limited Eating in Pediatric Weight Management. Tucker, JM., Siegel, R., Murray, PJ., et al.[2023]

The study demonstrated that an 8-week telephone-based weekday-only time-restricted eating (TRE) intervention was feasible and well-accepted among 22 breast cancer survivors aged 60 and older, with a high adherence rate of 98%.

Despite the successful implementation, there were no significant changes in metabolic syndrome components or lipid profiles, suggesting that longer intervention durations may be needed to achieve consistent metabolic improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of weekday time-restricted eating to improve metabolic health in breast cancer survivors with overweight/obesity. Kirkham, AA., Ford, KL., Ramos Da Silva, B., et al.[2023]

The ChronoFast trial will compare the effects of early time-restricted eating (eTRE) and late time-restricted eating (lTRE) on cardiometabolic health in 30 women with overweight or obesity over a 2-week period, focusing on insulin sensitivity and other health markers.

This study employs rigorous methods, including real-time dietary monitoring and continuous glucose tracking, to ensure compliance and assess the effectiveness of each eating pattern, aiming to provide clear recommendations for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Early vs. Late Time-Restricted Eating on Cardiometabolic Health, Inflammation, and Sleep in Overweight and Obese Women: A Study Protocol for the ChronoFast Trial. Peters, B., Koppold-Liebscher, DA., Schuppelius, B., et al.[2021]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06491537

Time-restricted Eating for Postpartum Weight Loss Timing-based interventions, such as early time-restricted eating (eTRE), show significant improvements in cardiometabolic endpoints in non-postpartum cohorts.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35939311/

Effectiveness of Early Time-Restricted Eating for Weight Loss ... In this randomized clinical trial, eTRE was more effective for losing weight and improving diastolic blood pressure and mood than eating over a window of 12 or ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522045488

Effectiveness of a weight loss intervention in postpartum ... The primary outcome was change in body weight after 12 wk and 1 y. The retention rate was 91% and 85% at 12 wk and 1 y, respectively. Results: At baseline, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9361187/

Effectiveness of Early Time-Restricted Eating for Weight ... Early time-restricted eating was more effective for weight loss than eating over a window of 12 or more hours; larger studies are needed on fat ...

5. mdpi.com mdpi.com/2072-6643/17/6/1022

Early Time-Restricted Eating Improves Weight Loss While ... Many studies suggest that TRE not only helps to mitigate excessive energy intake but also helps to align meal timings with the body's circadian rhythms.

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2794819

Effectiveness of Early Time-Restricted Eating for Weight ... In a secondary analysis of completers, early time-restricted eating was more effective for losing weight and body fat. Meaning Early time- ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2114833

Calorie Restriction with or without Time-Restricted Eating ... In this 12-month trial, we found that the 8-hour time-restricted–eating regimen did not produce greater weight loss than the regimen of daily ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224027287

Weight-neutral early time-restricted eating improves ... This 6-day randomized crossover supervised feeding trial demonstrates that weight-neutral eTRE reduces glycemic variability by 17% and time in ...