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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.
This program is designed to reduce postpartum weight retention in low income women in the WIC program. The weight loss program will be delivered over the internet and will use behavioral weight loss techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention. |
|
| Standard WIC care | No Intervention | The control group will received Standard Care as provided through WIC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online postpartum weight control | Behavioral | The intervention group will be given access to an online weight loss program supplemented by monthly group meetings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Calorie Intake | Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Phelan, PhD. | California Polytechnic State University-San Luis Obispo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Polytechnic State University | San Luis Obispo | California | 93401 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28632867 | Background | Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Munoz-Christian K, Tate DF. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2381-2391. doi: 10.1001/jama.2017.7119. | |
| 28816589 | Background | Martin CL, Tate DF, Schaffner A, Brannen A, Hatley KE, Diamond M, Munoz-Christian K, Pomeroy J, Sanchez T, Mercado A, Hagobian T, Phelan S. Acculturation Influences Postpartum Eating, Activity, and Weight Retention in Low-Income Hispanic Women. J Womens Health (Larchmt). 2017 Dec;26(12):1333-1339. doi: 10.1089/jwh.2016.6154. Epub 2017 Aug 17. |
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12 WIC Clinics Recruited; 371 participants total across all clinics
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention. Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings. |
| FG001 | Standard WIC Care | The control group will received Standard Care as provided through WIC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Across the 11 clinics, 371 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention. Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight | Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months. | This cluster randomized trial included 11 clinics. Participant numbers reflect number of people randomized within the clinics. | Posted | Least Squares Mean | 95% Confidence Interval | kg | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention. Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-reported injury from physical activity | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Phelan | Cal Poly | 805 756 2087 | sphelan@calpoly.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Chapel Hill |
| North Carolina |
| United States |
| 25887964 | Result | Phelan S, Brannen A, Erickson K, Diamond M, Schaffner A, Munoz-Christian K, Stewart A, Sanchez T, Rodriguez VC, Ramos DI, McClure L, Stinson C, Tate DF. 'Fit Moms/Mamas Activas' internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial. Trials. 2015 Feb 25;16:59. doi: 10.1186/s13063-015-0573-9. |
| 32888250 | Derived | Bennion KA, Tate D, Munoz-Christian K, Phelan S. Impact of an Internet-Based Lifestyle Intervention on Behavioral and Psychosocial Factors During Postpartum Weight Loss. Obesity (Silver Spring). 2020 Oct;28(10):1860-1867. doi: 10.1002/oby.22921. Epub 2020 Sep 4. |
| Standard WIC Care |
The control group will received Standard Care as provided through WIC. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The control group will received Standard Care as provided through WIC. |
|
|
|
| Secondary | Calorie Intake | Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months. | 12 clusters were randomized. Sample size above reflect total number of participants in each group. | Posted | Least Squares Mean | 95% Confidence Interval | kcal/day | 12 months |
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|
|
| 0 |
| 174 |
| 16 |
| 174 |
| EG001 | Standard WIC Care | The control group will received Standard Care as provided through WIC. | 0 | 196 | 15 | 196 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |