Time-restricted Eating for Postpartum Weight Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alabama at Birmingham
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Experienced a healthy singleton pregnancy
6-16 weeks postpartum at enrollment
Body mass index ≥25 at enrollment
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Early Time-Restricted Eating (eTRE)
Behavioral12 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.
Control
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: eTRE InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Study Participation Rate
Percentage of eligible subjects who agreed to participate out of those who were screened.
Time frame
Baseline (6-16 weeks postpartum)2
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.
Time frame
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)3
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.
Time frame
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)4
Participant Retention
The proportion of enrolled participants who complete follow-up.
Time frame
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov