Weight, Body, Weight Loss
Conditions
Brief summary
The overall goal of the study is to develop a novel weight loss intervention for postpartum people by providing strategies to improve sleep, diet, and physical activity behaviors. In this study, we will recruitment and enroll 40 postpartum people and randomize them to receive the Sleep GOALS intervention or education control to evaluate the intervention's feasibility, acceptability, and preliminary efficacy.
Interventions
BEHAVIORALSleep GOALS
Web-based interventions
BEHAVIORALEducation
Brochures from the American Academy of Sleep Medicine (e.g., sleep hygiene, sleep in women) and SNAP education connection (e.g., family-friendly activities, meal planning)
Sponsors
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
16-week pilot study will use a single-blind, parallel-arm randomized controlled trial design. Participants will be randomized at a 1:1 ratio to Sleep GOALS intervention (n=20) or an education control group (n=20)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Stated willingness to comply with all study procedures and availability for the duration of the study, * Primiparous, singleton pregnancy, * Between 3+1 and 6+1 months postpartum, * Has a body mass index \>25 kg/m2, * Physically inactive, defined as self-reporting \<150 minutes/week of moderate-to-vigorous intensity physical activity, * Endorse \>1 indicator of poor sleep health based on the RU\_SATED questionnaire, and * Has smartphone and home Internet access
Exclusion criteria
* current use of medications that affect weight, * currently pregnant or plan to become pregnant during the study period (18 weeks), and * participating in another weight loss intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment - Number of the Total Sample | Baseline | The number of participants enrolled in 12 months |
| Recruitment - Proportion of Ethnic Minority | Baseline | The proportion of ethnic minority participants was calculated as the percentage of participants who did not identify as Non-Hispanic White. For this study, 'Ethnic Minority' includes participants who self-identified as: (1) Hispanic or Latino (of any race), or (2) Non-Hispanic and any of the following races: American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or More than One Race. |
| Retention Rate | Post-intervention at week 17 | Retention rate is defined as the number of participants who completed the final study visit at week 17, divided by the total number of participants randomized in each arm. |
| Engagement - Number of Modules Completed | Week 1 to 16 | The number of modules completed within 16 weeks |
| Engagement - Number of Self-monitoring of Diet, Sleep and Physical Activity Weekly | Week 1 to 16 | The number of weeks in which self-monitoring of diet, sleep, and physical activity is performed at least once a week |
| Engagement - Number of Weekly Weigh-ins | Week 1 to 16 | The number of weeks in which weigh-in is performed at least once a week |
| Engagement - Total Time Logged in | Week 1 to 16 | Total time logged in during the 16-week intervention |
| Acceptability - Proportion of Agreeing | Assessed weekly from Week 1 to Week 16; average score across all weeks reported. | Acceptability was assessed using a weekly 3-item intervention acceptability questionnaire focused on the participants' experience with the intervention. This outcome specifically reports on three key items: (1) the usefulness of implementing weekly action plans, (2) the clarity of content regarding overcoming barriers or challenges, and (3) the ease of using the intervention platform. Participants rated their level of agreement with statements such as 'The weekly action plans were useful for my behavior change' and 'The materials clearly addressed how to manage barriers.' Each item scored from 1 to 5 (1=Strongly Disagree to 5=Strongly Agree). A higher score represents a higher level of acceptability. Acceptability scores were assessed weekly from Week 1 to Week 16. The value reported represents the average score across all 16 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | Baseline and Post-intervention at week 17 | Baseline and post-intervention differences in weight. Weight was measured with a digital scale, with the participant wearing light clothing at baseline and post-intervention. |
| Number of Participants With Postpartum Weight Retention >11 Lbs | Post-intervention at week 17 | Postpartum Weight Retention was calculated as the difference between the measured weight at post-intervention and the self-reported pre-pregnancy weight. This measure reports the number of participants who retained more than 11 pounds of weight compared to their pre-pregnancy weight. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarquis Hawkins, PhD
University of Pittsburgh
Participant flow
Recruitment details
Participants were recruited from Allegheny County, Pennsylvania, using multiple strategies, including a university-based research registry (Pitt+Me), university-wide email listservs, online recruitment platforms, targeted mailings through obstetric databases, community-based organizations, and clinician referral programs. Recruitment occurred over approximately 11 months at academic medical and community-affiliated clinical settings.
Pre-assignment details
After initial eligibility pre-screening, eligible participants provided written informed consent. Baseline assessments were completed prior to randomization. Participants were excluded before assignment if they no longer met eligibility criteria, including changes in pregnancy status, initiation of another weight-loss intervention, or identification of medical contraindications to physical activity.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 31.9 years STANDARD_DEVIATION 4.1 |
| Depressive Symptoms | 7.1 Score on a scale STANDARD_DEVIATION 4.2 |
| Diet Quality | 48.3 Score on a scale STANDARD_DEVIATION 12.8 |
| Education 9th - 12th grade, no diploma | 1 Participants |
| Education Associate/technical degree | 1 Participants |
| Education Bachelor's degree | 6 Participants |
| Education Doctorate or Professional degree | 9 Participants |
| Education Master's degree | 14 Participants |
| English Language Proficiency Not at all | 0 Participants |
| English Language Proficiency Not well | 0 Participants |
| English Language Proficiency Very well | 38 Participants |
| English Language Proficiency Well | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Income $100,000-$149,999 | 5 Participants |
| Income $150,000-$199,999 | 3 Participants |
| Income $15,000-$19,999 | 1 Participants |
| Income $200,000 or more | 3 Participants |
| Income $20,000-$29,999 | 0 Participants |
| Income $30,000-$39,999 | 1 Participants |
| Income $40,000-$49,999 | 2 Participants |
| Income $50,000-$59,999 | 0 Participants |
| Income $60,000-$74,999 | 4 Participants |
| Income $75,000-$99,999 | 0 Participants |
| Income Don't know | 1 Participants |
| Income Prefer not to answer | 1 Participants |
| Marital Status Married | 18 Participants |
| Marital Status Single, never married | 1 Participants |
| Multidimensional Sleep Health | 6.3 Score on a scale STANDARD_DEVIATION 1.7 |
| Number of people in household | 3.3 people STANDARD_DEVIATION 0.8 |
| Physical Activity At or above median | 21 Participants |
| Physical Activity Below median | 10 Participants |
| Postpartum Functioning | 93.7 Score on a scale STANDARD_DEVIATION 13.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
| Stress | 20.6 Score on a scale STANDARD_DEVIATION 6.5 |
| Weight | 185.5 lbs STANDARD_DEVIATION 36.1 |
| Years in the US | 29.6 years STANDARD_DEVIATION 8.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed