Overweight and Obesity, Postpartum Weight Retention
Conditions
Keywords
postpartum, weight management, time-restricted eating
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).
Interventions
BEHAVIORALEarly Time-Restricted Eating (eTRE)
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.
BEHAVIORALControl
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.
Sponsors
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | 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 | 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 | Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) | The proportion of enrolled participants who complete follow-up. |
| Change in Visceral Fat | 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 | 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 | 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 | 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 | 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 | 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). |
| Study Participation Rate | Baseline (6-16 weeks postpartum) | Percentage of eligible subjects who agreed to participate out of those who were screened. |
Countries
United States
Contacts
CONTACTCamille S Worthington, PhD
PRINCIPAL_INVESTIGATORCamille Worthington, PhD
University of Alabama at Birmingham
Outcome results
None listed