Feasibility of Meal Delivery Postpartum
Study Details
Study Description
Brief Summary
This study is being done to assess the feasibility and acceptability of a meal delivery intervention among low-income postpartum women with obesity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a single-group pilot study in which subjects will receive 10 home-delivered meals per week for 8 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Meal Delivery Meal delivery intervention program designed to help low income postpartum women lose weight through weekly meal delivery and behavioral strategies. |
Behavioral: Meal Delivery
10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.
|
Outcome Measures
Primary Outcome Measures
- Participant Adherence to Intervention [Collected weekly from intervention start (6-21 weeks postpartum) to follow-up (14-29 weeks postpartum)]
Proportion of weekly study meals participants consumed based on responses to weekly electronic surveys in which participants will report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.
Secondary Outcome Measures
- Study Participation Rate [baseline (5-19 weeks postpartum)]
Percentage of eligible subjects who agreed to participate out of those who were screened
- Participant Retention [baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)]
The proportion of enrolled participants who complete follow-up
- Change in Participant Satisfaction with Diet [baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)]
To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses are average to produce a total diet satisfaction score ranging from 1-5. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning & Preparation Factor will be examined from baseline to follow-up.
Other Outcome Measures
- Change in Weight [baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)]
Body weight measured at baseline and follow-up will be used to calculate weight change.
- Change in Food Security [baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)]
Determined using the 18-item United States (US) Household Food Security Survey Module based on the previous 30 days. Adult food security scores range from 0 to 10, with lower values indicating greater food security.
- Change in Perceived Stress [baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)]
Determined using the 10-item Perceived Stress Scale (PSS-10) based on the last month. PSS-10 scores range from 0 to 40, with higher scores representing higher levels of perceived stress.
- Change in Healthy Eating Self-Efficacy [baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)]
Participants will be asked to score 3 statements on a 5-point Likert scale ranging from 1=very sure to 5=very unsure (adapted from Lipsky LM et al. 2016). Responses are reverse coded and averaged, so higher scores reflect increasing self-efficacy.
- Change in Weight Control Self-Efficacy [baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)]
Participants will be asked to score 3 statements on a 5-point Likert scale ranging from 1=very sure to 5=very unsure (adapted from Lipsky LM et al. 2016). Responses are reverse coded and averaged, so higher scores reflect increasing self-efficacy.
- Change in Healthy Eating Index score from baseline to follow-up [three 24-hour dietary recalls on non-consecutive days at baseline (5-19 weeks postpartum) and follow-up (14-29 weeks postpartum)]
Determined based on the Healthy Index Score, in which 100 indicates complete alignment with the Dietary Guidelines for Americans and 0 is the minimum score, as calculated from three 24-hour dietary recalls conducted on non-consecutive days (2 weekdays + 1 weekend day) at each time point.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
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18 years of age or older
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Initiated prenatal care at a University of Alabama at Birmingham prenatal clinic
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Experienced a healthy singleton pregnancy
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5-18 weeks postpartum at enrollment
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Body mass index >= 30 at enrollment
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Residing within the meal company's delivery radius
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Willing to consent
Exclusion Criteria:
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Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
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Current treatment for severe psychiatric disorder (such as schizophrenia)
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Self-reported diagnosis of anorexia or bulimia
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Current use of medication expected to significantly impact body weight
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Current substance abuse
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Participation in another dietary and/or weight management intervention postpartum
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Unable to understand and communicate in English
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Unwilling or unable to consume study meals
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Camille S Worthington, PhD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300010155