Obesity, Postpartum Weight Retention
Conditions
Keywords
Postpartum, Weight management, Meal delivery
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.
Detailed description
This is a single-group pilot study in which subjects will receive 10 home-delivered meals per week for 8 weeks.
Interventions
10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.
Sponsors
Study design
Masking description
All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
Eligibility
Inclusion criteria
* Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line * 18 years of age or older * Initiated prenatal care at a University of Alabama at Birmingham prenatal clinic * Experienced a healthy singleton pregnancy * 5-45 weeks postpartum at enrollment * Body mass index \>= 30 at enrollment * Residing within the meal company's delivery radius * 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 * Unable to understand and communicate in English * Unwilling or unable to consume study meals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Proportion of Received Study Meals Consumed | Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum) | Proportion of received weekly study meals participants reported consuming each week collected via weekly electronic surveys in which participants will self-report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Participation Rate | baseline (5-45 weeks postpartum) | Total number of eligible subjects who agreed to participate out of those who were screened. |
| Participant Retention | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) | The number of enrolled participants who completed some or all follow-up assessment visit measurements. |
| Change in Participant Satisfaction With Diet | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) | To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses to all 28-items are averaged to produce a total diet satisfaction score (designed to reflect satisfaction as it relates to following a weight-management diet) ranging from 1-5. Subscale scores for Cost Factor (reflects financial cost of the diet) and Planning & Preparation Factor (reflects amount of time and effort spent in planning and preparing) will also be calculated and range from 1-5. For the overall diet satisfaction score and subscale scores, higher scores represent greater satisfaction. 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) | Body weight measured at baseline and follow-up will be used to calculate weight change. |
| Change in Weight Control Self-Efficacy | baseline (5-45 weeks postpartum), follow-up (14-53 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 Food Security | baseline (5-45 weeks postpartum), follow-up (14-53 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 (5-45 weeks postpartum), follow-up (14-53 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 (5-45 weeks postpartum), follow-up (14-53 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. |
Countries
United States
Participant flow
Pre-assignment details
Not applicable as there was no randomization. All participants began receiving the meal delivery intervention after completing enrollment and baseline assessment measures.
Participants by arm
| Arm | Count |
|---|---|
| Meal Delivery Meal delivery intervention program designed to help low-income postpartum women lose weight through weekly meal delivery and behavioral strategies.
Meal Delivery: 10 home-delivered meals per week for 8 weeks provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Meal Delivery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 31.5 years STANDARD_DEVIATION 4.7 |
| Body Weight | 100.3 kilograms STANDARD_DEVIATION 15.4 |
| Diet Satisfaction- Cost Factor | 2.87 score on a scale STANDARD_DEVIATION 0.72 |
| Diet Satisfaction-Planning & Preparation Factor | 3.44 score on a scale STANDARD_DEVIATION 0.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Food Security Score | 1.5 score on a scale STANDARD_DEVIATION 2.8 |
| Healthy Eating Self-Efficacy | 3.8 score on a scale STANDARD_DEVIATION 0.6 |
| Participant Overall Satisfaction with Diet | 2.95 score on a scale STANDARD_DEVIATION 0.42 |
| Perceived Stress | 12.7 score on a scale STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight Control Self-Efficacy | 3.0 score on a scale STANDARD_DEVIATION 0.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Self-Reported Proportion of Received Study Meals Consumed
Proportion of received weekly study meals participants reported consuming each week collected via weekly electronic surveys in which participants will self-report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.
Time frame: Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum)
Population: The total number of meals received were analyzed to determine the average proportion of provided study meals the participant reportd they ate, others in the household ate, and that were thrown away/frozen/uneaten per week. One participant did not receive meals for 2 weeks due to delivery errors, which is why the total units analyzed is 620.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meal Delivery | Self-Reported Proportion of Received Study Meals Consumed | Proportion of Meals Participant Ate | 0.86 Proportion of Received Meals | Standard Deviation 0.25 |
| Meal Delivery | Self-Reported Proportion of Received Study Meals Consumed | Proportion of Meals Someone Else in Household Ate | 0.05 Proportion of Received Meals | Standard Deviation 0.11 |
| Meal Delivery | Self-Reported Proportion of Received Study Meals Consumed | Proportion of Meals thrown away/frozen/uneaten | 0.09 Proportion of Received Meals | Standard Deviation 0.24 |
Change in Participant Satisfaction With Diet
To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses to all 28-items are averaged to produce a total diet satisfaction score (designed to reflect satisfaction as it relates to following a weight-management diet) ranging from 1-5. Subscale scores for Cost Factor (reflects financial cost of the diet) and Planning & Preparation Factor (reflects amount of time and effort spent in planning and preparing) will also be calculated and range from 1-5. For the overall diet satisfaction score and subscale scores, higher scores represent greater satisfaction. 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.
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in score (which reflects an increase in satisfaction) from baseline to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meal Delivery | Change in Participant Satisfaction With Diet | Change in overall diet satisfaction score | 0.17 score on a scale | Standard Deviation 0.5 |
| Meal Delivery | Change in Participant Satisfaction With Diet | Change in Cost Factor Score | 0.3 score on a scale | Standard Deviation 0.8 |
| Meal Delivery | Change in Participant Satisfaction With Diet | Change in Planning & Preparation Factor Score | -0.2 score on a scale | Standard Deviation 0.9 |
Participant Retention
The number of enrolled participants who completed some or all follow-up assessment visit measurements.
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Population: The overall number of participants analyzed (N=11) reflects the number of participants who enrolled in the study, including those who completed all of the 8-week follow-up assessment measurements, those who completed some (but not all) of the 8-week follow-up assessment measurements, and those that did not complete any of the 8-week follow-up assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Meal Delivery | Participant Retention | Completed all follow-up measurements | 6 Participants |
| Meal Delivery | Participant Retention | Completed some (but not all) follow up measurements | 2 Participants |
Study Participation Rate
Total number of eligible subjects who agreed to participate out of those who were screened.
Time frame: baseline (5-45 weeks postpartum)
Population: The overall Number of Participants Analyzed (N=24) reflects the total number of participants who were screened, including those who may not have been eligible/consented into the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meal Delivery | Study Participation Rate | 11 Participants |
Change in Food Security
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.
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Population: Change calculated as food security score at 8-week follow up minus score at baseline, with negative values indicating an increase in food security from baseline to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal Delivery | Change in Food Security | -0.5 score on a scale | Standard Deviation 0.8 |
Change in Healthy Eating Self-Efficacy
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.
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in self-efficacy from baseline to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal Delivery | Change in Healthy Eating Self-Efficacy | -0.6 score on a scale | Standard Deviation 0.9 |
Change in Perceived Stress
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.
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in perceive stress score from baseline to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal Delivery | Change in Perceived Stress | 1.8 score on a scale | Standard Deviation 5.9 |
Change in Weight
Body weight measured at baseline and follow-up will be used to calculate weight change.
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Population: Change calculated as weight at 8-week follow up minus weight at baseline, with negative values indicating weight loss from baseline to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal Delivery | Change in Weight | -0.18 kilograms | Standard Deviation 4.77 |
Change in Weight Control Self-Efficacy
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.
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in self-efficacy from baseline to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal Delivery | Change in Weight Control Self-Efficacy | 0.38 score on a scale | Standard Deviation 0.57 |