Postpartum Weight RetentionTime4MomNCT06491537
Time-restricted Eating for Postpartum Weight Loss
A study testing Early Time-Restricted Eating (eTRE) in people with Postpartum Weight Retention and Overweight and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Weight Retention, Overweight and Obesity
- What is being tested?
- Early Time-Restricted Eating (eTRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Experienced a healthy singleton pregnancy
- 6-16 weeks postpartum at enrollment
- Body mass index ≥25 at enrollment
- Willing to consent
Who cannot join
- Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
- Current treatment for severe psychiatric disorder (such as schizophrenia)
- Self-reported diagnosis of anorexia or bulimia
- Current use of medication expected to significantly impact body weight
- Current substance abuse
- Participation in another dietary and/or weight management intervention postpartum
Show all 9Show fewer
- Performing overnight shiftwork >1x/week
- Regularly fasting ≥14 hr/day or completing twelve or more 24-hr fasts within the past year
- Unable to understand and communicate in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Camille S Worthington, PhD, 205-975-7274, cschneid@uab.edu
About this study
Official title: Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.
Read the detailed description
Existing postpartum weight retention (PPWR) interventions have had limited success. Timing-based interventions, such as early time-restricted eating (eTRE), show significant improvements in cardiometabolic endpoints in non-postpartum cohorts. The purpose of the Time4Mom study is to conduct a pilot randomized trial of a postpartum-adapted eTRE intervention to test feasibility and acceptability of the eTRE intervention and trial protocol. We will also compare changes in clinical outcomes of interest and patient-reported outcomes between eTRE (intervention) and control groups.
This 2-arm trial will randomize 60 postpartum women to either Control or eTRE for 12 weeks (n=30/group).
- Being tested
- Early Time-Restricted Eating (eTRE), Control
- Keywords
- postpartum, weight management, time-restricted eating
- Medical subject headings
- Gestational Weight Gain, Overweight, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time-Restricted Eating (eTRE)Behavioural
Also called Intermittent Fasting, Timed Eating
12 weeks of eTRE intervention. Study staff will provide 7 support sessions with brief behavioral support, including evidence based strategies of problem-solving, action planning, and motivational interviewing.
ControlBehavioural
The control group will be instructed to maintain their average eating window for the 12-week period. Study staff will contact participants 7 times to encourage maintenance.
| Study group | Role | What they receive |
|---|---|---|
| eTRE Intervention | Experimental | A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist. Receives: Behavioral: Early Time-Restricted Eating (eTRE) |
| Control | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Participation Rate
Percentage of eligible subjects who agreed to participate out of those who were screened.
Measured: Baseline (6-16 weeks postpartum)
Oral Glucose Tolerance Test (OGTT)
Indices of glucose tolerance and insulin action will be assessed via a 2-hr OGTT. Participants will consume a 75-g glucose load within 5 minutes, which will be timed to begin at each participant's habitual breakfast time. Fasting blood samples will be collected at 15-, 30-, 60-, 90-, and 120-minutes relative to glucose consumption.
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Energy Intake
Dietary intake will be collected at each assessment by 3 self-administered 24-hr recalls on 3 non-consecutive days (2 weekdays, 1 weekend day) using the Automatic Self-Administered 24-hour Dietary Assessment Tool (ASA24), an online platform developed and hosted by the National Cancer Institute. Total energy intake and kcals from each macronutrient will be derived from 24-hr recalls.
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Participant Retention
The proportion of enrolled participants who complete follow-up.
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Change in Visceral Fat
Bioelectrical impedance analysis (BIA) (seca® mBCA 514) will be used to assess visceral adipose tissue.
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Participant Adherence to Intervention
Adherence to eating window based on responses to daily electronic REDCap surveys that record start and stop time of the eating window.
Measured: Collected daily from intervention start (6-16 weeks postpartum) to follow-up (18-28 weeks postpartum)
eTRE Intervention Satisfaction
Participant satisfaction with the eating schedule will be assessed using a 5-point Likert scale. Long-term eating schedule preferences will be assessed by asking intervention participants at follow-up whether they plan to: (a) continue following the assigned eTRE schedule; (b) follow a modified eTRE schedule [and specifying what modifications they plan to make]; or (c) stop eTRE and return to prior meal timing habits.
Qualitative data on eTRE intervention satisfaction will be collected at follow-up. These one-on-one interviews will be conducted in-person or remotely via videoconferencing. Topics explored will include participants' typical day during the intervention, experiences with eTRE, adherence barriers/facilitators, intervention satisfaction, and suggested improvements.
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Change in Body Weight
Body weight measured at baseline and follow-up will be used to calculate weight change.
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Change in Subjective Appetite
Subjective ratings of appetite (hunger and satiety) over the past week will be collected at baseline and follow-up using visual analogue scales scored from 0 (less hunger/less satiety) to 100 (more feelings of hunger/more feelings of satiety) based on the response along a 100-mm line.
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Self-Reported Fatigue
Fatigue will be assessed using the NIH's validated 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 8a to assess fatigue over the past 7 days. The PROMIS Fatigue SF 8a is scored on a T-score metric with a mean of 50 and standard deviation of 10. The T-score metric is referenced to the US general population with respect to race/ethnicity, age, education, and sex (e.g., T-score of 40 would be one SD below the US general population). A higher PROMIS T-score represents more of the concept being measured (higher score indicates more fatigue).
Measured: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start22 May 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Weight RetentionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Camille S Worthington, PhD, University of Alabama at Birmingham
- Investigators
- Camille Worthington, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491537
- Sponsor's protocol ID
- IRB-300012535
- Other IDs
- K23HD108345
- Acronym
- Time4Mom
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data produced during the project will be preserved and shared: Aggregate data on recruitment rates and reasons for refusal, retention rates, adherence rates, and treatment satisfaction will be shared publicly. Individual participant data (IPD) for the following measures will be restricted with a data use agreement: anthropometrics (weight, height, waist circumference); body composition; the following serum levels at each timepoint from the oral glucose tolerance test: insulin, glucose, and c-peptide; dietary data; survey responses/total scores; demographics; and pregnancy-related medical history. All aggregate datasets that can be shared publicly will be deposited in the Open Science Framework (OSF) generalist repository. De-identified IPD will be shared via controlled access in the Vivli repository.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
- ClinicalTrials.gov ID
- NCT06491537
- Acronym / sponsor ID
- Time4Mom / IRB-300012535
- Keywords
- postpartum, weight management, time-restricted eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.
Detailed description
Existing postpartum weight retention (PPWR) interventions have had limited success. Timing-based interventions, such as early time-restricted eating (eTRE), show significant improvements in cardiometabolic endpoints in non-postpartum cohorts. The purpose of the Time4Mom study is to conduct a pilot randomized trial of a postpartum-adapted eTRE intervention to test feasibility and acceptability of the eTRE intervention and trial protocol. We will also compare changes in clinical outcomes of interest and patient-reported outcomes between eTRE (intervention) and control groups.
This 2-arm trial will randomize 60 postpartum women to either Control or eTRE for 12 weeks (n=30/group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTRE Intervention | Experimental | Behavioral: Early Time-Restricted Eating (eTRE)A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist. |
| Control | Active comparator | Behavioral: ControlControl 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Experienced a healthy singleton pregnancy
- 6-16 weeks postpartum at enrollment
- Body mass index ≥25 at enrollment
- Willing to consent
Key exclusion criteria (9 listed)
- Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
- Current treatment for severe psychiatric disorder (such as schizophrenia)
- Self-reported diagnosis of anorexia or bulimia
- Current use of medication expected to significantly impact body weight
- Current substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Time-Restricted Eating (eTRE)Also: Intermittent Fasting, Timed Eating12 weeks of eTRE intervention. Study staff will provide 7 support sessions with brief behavioral support, including evidence based strategies of problem-solving, action planning, and motivational interviewing. | Behavioural | eTRE Intervention |
| ControlThe control group will be instructed to maintain their average eating window for the 12-week period. Study staff will contact participants 7 times to encourage maintenance. | Behavioural | Control |
Primary outcome
Study Participation Rate
Time frame: Baseline (6-16 weeks postpartum)
Percentage of eligible subjects who agreed to participate out of those who were screened.
Oral Glucose Tolerance Test (OGTT)
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Indices of glucose tolerance and insulin action will be assessed via a 2-hr OGTT. Participants will consume a 75-g glucose load within 5 minutes, which will be timed to begin at each participant's habitual breakfast time. Fasting blood samples will be collected at 15-, 30-, 60-, 90-, and 120-minutes relative to glucose consumption.
Energy Intake
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Dietary intake will be collected at each assessment by 3 self-administered 24-hr recalls on 3 non-consecutive days (2 weekdays, 1 weekend day) using the Automatic Self-Administered 24-hour Dietary Assessment Tool (ASA24), an online platform developed and hosted by the National Cancer Institute. Total energy intake and kcals from each macronutrient will be derived from 24-hr recalls.
Participant Retention
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
The proportion of enrolled participants who complete follow-up.
Change in Visceral Fat
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Bioelectrical impedance analysis (BIA) (seca® mBCA 514) will be used to assess visceral adipose tissue.
Participant Adherence to Intervention
Time frame: Collected daily from intervention start (6-16 weeks postpartum) to follow-up (18-28 weeks postpartum)
Adherence to eating window based on responses to daily electronic REDCap surveys that record start and stop time of the eating window.
eTRE Intervention Satisfaction
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Participant satisfaction with the eating schedule will be assessed using a 5-point Likert scale. Long-term eating schedule preferences will be assessed by asking intervention participants at follow-up whether they plan to: (a) continue following the assigned eTRE schedule; (b) follow a modified eTRE schedule [and specifying what modifications they plan to make]; or (c) stop eTRE and return to prior meal timing habits. Qualitative data on eTRE intervention satisfaction will be collected at follow-up. These one-on-one interviews will be conducted in-person or remotely via videoconferencing. Topics explored will include participants' typical day during the intervention, experiences with eTRE, adherence barriers/facilitators, intervention satisfaction, and suggested improvements.
Change in Body Weight
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Body weight measured at baseline and follow-up will be used to calculate weight change.
Change in Subjective Appetite
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Subjective ratings of appetite (hunger and satiety) over the past week will be collected at baseline and follow-up using visual analogue scales scored from 0 (less hunger/less satiety) to 100 (more feelings of hunger/more feelings of satiety) based on the response along a 100-mm line.
Self-Reported Fatigue
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Fatigue will be assessed using the NIH's validated 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 8a to assess fatigue over the past 7 days. The PROMIS Fatigue SF 8a is scored on a T-score metric with a mean of 50 and standard deviation of 10. The T-score metric is referenced to the US general population with respect to race/ethnicity, age, education, and sex (e.g., T-score of 40 would be one SD below the US general population). A higher PROMIS T-score represents more of the concept being measured (higher score indicates more fatigue).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. The following data produced during the project will be preserved and shared: Aggregate data on recruitment rates and reasons for refusal, retention rates, adherence rates, and treatment satisfaction will be shared publicly. Individual participant data (IPD) for the following measures will be restricted with a data use agreement: anthropometrics (weight, height, waist circumference); body composition; the following serum levels at each timepoint from the oral glucose tolerance test: insulin, glucose, and c-peptide; dietary data; survey responses/total scores; demographics; and pregnancy-related medical history. All aggregate datasets that can be shared publicly will be deposited in the Open Science Framework (OSF) generalist repository. De-identified IPD will be shared via controlled access in the Vivli repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille Worthington, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time-Restricted Eating (eTRE) in people with Postpartum Weight Retention and Overweight and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille S Worthington, PhD (205.975.7274, cschneid@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Participation Rate (time frame: Baseline (6-16 weeks postpartum)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.