This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGStudy Participation Rate
Percentage of eligible subjects who agreed to participate out of those who were screened.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Participant Retention
The proportion of enrolled participants who complete follow-up.
Time frame: 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.
Time frame: 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.
Time frame: Collected daily from intervention start (6-16 weeks postpartum) to follow-up (18-28 weeks postpartum)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)