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 study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.

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.

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) has been studied in overweight and obese adults and appears to be safe, with some studies showing improvements in metabolic health, such as reduced blood pressure and better glucose control. However, larger studies are needed to fully understand its safety and effects on overall health. ^{1 2 3 4 5}

How does early time-restricted eating (eTRE) differ from other treatments for postpartum weight loss?

Early time-restricted eating (eTRE) is unique because it involves eating within a specific early time window, such as from 7 a.m. to 1 p.m., which may improve metabolic health and aid weight loss by reducing blood pressure, glucose, and insulin levels. Unlike other weight loss methods that often require calorie counting, eTRE focuses on timing, making it a potentially simpler and more sustainable option. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Early Time-Restricted Eating (eTRE) for postpartum weight loss?

Research shows that early time-restricted eating (eTRE), where eating is limited to early hours of the day, can lead to weight loss and improve metabolic health, such as reducing blood pressure and insulin levels, in overweight and obese individuals. This suggests that eTRE might also be effective for postpartum weight loss. ^{1 2 3 8 9}

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

I gave birth 6 to 16 weeks ago.

Experienced a healthy singleton pregnancy

Willing to consent

Exclusion Criteria

Participation in another dietary and/or weight management intervention postpartum

I have a major health condition like kidney disease, cancer, or diabetes.

I am not currently being treated for a severe psychiatric disorder.

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 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]

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]

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

Randomized controlled trial for time-restricted eating in overweight and obese young adults. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptability of Time-Limited Eating in Pediatric Weight Management. [2023]

3. Switzerland 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. [2021]

4. England 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. [2021]

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

Implementation of weekday time-restricted eating to improve metabolic health in breast cancer survivors with overweight/obesity. [2023]

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

Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial. [2022]

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

Time limited eating in adolescents with obesity (time LEAd): Study protocol. [2021]

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

Is time-restricted eating (8/16) beneficial for body weight and metabolism of obese and overweight adults? A systematic review and meta-analysis of randomized controlled trials. [2023]

9. United States 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. [2023]