Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Study Participation Rate
研究概览
简要总结
This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
eTRE Intervention
A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.
干预措施: Early Time-Restricted Eating (eTRE) (Behavioral)
Control
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.
干预措施: Control (Behavioral)
结局指标
主要结局
Study Participation Rate
时间窗: Baseline (6-16 weeks postpartum)
Percentage of eligible subjects who agreed to participate out of those who were screened.
Oral Glucose Tolerance Test (OGTT)
时间窗: 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
时间窗: 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
时间窗: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
The proportion of enrolled participants who complete follow-up.
Change in Visceral Fat
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Camille S Worthington, PhD
Primary Investigator
University of Alabama at Birmingham