What is the clinical evidence from this study?

Study design: RCT. Population: Postpartum weight retention (n=40). Intervention: Sleep GOALS vs. Educational brochure. Primary outcome: Feasibility and acceptability.

What question did this study set out to answer?

This trial aimed to assess the feasibility, acceptability, and preliminary efficacy of an integrated intervention focusing on sleep, diet, and physical activity in postpartum individuals.

May 10, 2026

0197 Sleep Goal-Focused Online Access to Lifestyle Support (GOALS) Trial: An Integrated Postpartum Sleep, Diet, and Physical Activity Intervention

Key Result

The 16-week Sleep GOALS intervention demonstrated high acceptability and resulted in a greater proportion of postpartum women achieving ≥5% weight loss compared to control (36% vs. 23%).

Key Points

This trial aimed to assess the feasibility, acceptability, and preliminary efficacy of an integrated intervention focusing on sleep, diet, and physical activity in postpartum individuals.
Randomized participants (2–7 months postpartum; BMI 25–40 kg/m²) into Sleep GOALS or educational control over 16 weeks.
Assessed feasibility and acceptability benchmarks including enrollment, retention, and module completion rates.
Performed analyses using descriptive statistics and linear mixed-effects models.
36% of participants in the intervention achieved ≥5% weight loss compared to 23% in the control.
Intervention group showed improvements in total active time (MD = -44.22 min/day, d = -0.46) and sleep continuity measures (MD = 0.52 hr/day, d = 0.59).
Control group had greater increases in total sleep duration (MD = 0.56 hr/day, d = 0.33) and reductions in perceived stress (MD = 4.45 points, d = -0.31).

Study Design

Type

RCT (n=40)

Structured PICO

Does the Sleep GOALS online intervention improve feasibility, acceptability, and preliminary efficacy for weight, sleep, and physical activity in postpartum individuals with overweight or obesity?

Population

40 postpartum individuals (2-7 months postpartum) with BMI 25-40 kg/m²

Intervention

Sleep GOALS (an online postpartum intervention integrating strategies to address sleep, diet, and physical activity) for 16 weeks

Comparator

Educational brochure

Outcome

Feasibility (enrollment, retention, module completion) and acceptability (survey assessing understanding, implementation, and barriers)patient reported

The Sleep GOALS online intervention demonstrated high acceptability and preliminary efficacy for weight loss and sleep continuity in postpartum individuals, though trial procedures require strengthening before a fully powered RCT.

Limitations

Recruitment and retention did not meet a priori benchmarks

Abstract

Abstract Introduction Postpartum weight retention contributes to long-term cardiometabolic risk. Postpartum diet and physical activity interventions yield modest effects on weight, with sleep, an essential determinant of weight, often overlooked. This study evaluated the feasibility, acceptability, and preliminary efficacy of Sleep GOALS, an online postpartum intervention integrating strategies to address sleep, diet, and physical activity. Methods This two-arm, 16-week pilot trial randomized participants (2–7 months postpartum; BMI 25–40 kg/m²) to Sleep GOALS or an educational brochure. Feasibility benchmarks were: enrollment of 40 participants over 1 year, ≥30% from racially diverse backgrounds, 80% retention at follow-up, and 80% of participants completing ≥70% of 16 modules. Acceptability benchmarks were mean scores ≥4/5 on a survey assessing understanding, implementation, and barriers. Secondary outcomes included changes in weight, sleep, physical activity, diet, and maternal psychosocial functioning. Analyses included descriptive statistics and linear mixed-effects models. Mean differences (MD) were calculated as intervention minus control. Results Forty individuals were enrolled, with 20% from racially diverse backgrounds. Study retention was 70%. On average, participants completed 72% modules. Acceptability was high, with most lessons rated 4 for ease of understanding, implementation, and minimal barriers. The intervention resulted in a greater proportion achieving ≥5% weight loss (36% vs. 23%). Between-group differences favored the intervention for total active time (MD = -44.22 min/day; d = -0.46) and light-intensity activity (MD = -28.64 min/day; d = -0.32). Sleep continuity (improvement favored the intervention, including wake after sleep onset MD = 0.52 hr/day; d = 0.59; number of awakenings MD = 3.17; d = 0.82), and improved sleep regularity (MD = -5.54 points; d = -0.35). The control included larger increases in total duration (MD = 0.56 hr/day; d = 0.33) and greater reductions in perceived stress (MD = 4.45 points; d = -0.31). Depressive symptoms, functioning, and diet quality improved similarly across groups. Conclusion Sleep GOALS demonstrated strong acceptability and produced encouraging signals of efficacy for physical activity and sleep continuity indicators. Recruitment and retention did not meet a priori benchmarks, highlighting opportunities to strengthen trial procedures before testing in a fully powered RCT. Support (if any) NHLBI 1K01 HL161439-01 (PI: Hawkins)

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