Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postpartum Weight Retention
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Study Participation Rate
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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).
Investigators
Camille S Worthington, PhD
Primary Investigator
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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).