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Madres Para la Salud (Mothers for Health)

Primary Purpose

Overweight and Obesity, Depression, Postpartum, Mother (Person)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Madres para la Salud
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring Hispanic Women, Postpartum, Overweight Hispanic Women, Low-income, Physical Activity, Walking

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Hispanic descendent
  • Between 18 and 40 years old
  • At least 6-weeks but less than 6-months post childbirth
  • Sedentary (according to the American College of Sports Medicine)
  • Have the ability to participate in moderate intensity physical activity (according to the Physical Activity Readiness Questionnaire (PAR-Q))

Exclusion Criteria:

  • Pregnant or planning a pregnancy in the next 12 months
  • Have a BMI less than 25 or greater than 35
  • Take anti-depressant medications
  • Take anticoagulants or herbal therapy to thin the blood
  • Participate in regular, strenuous physical activity (exceeding 150 minutes of moderate physical activity per week)
  • Severe musculoskeletal or cardiorespiratory problems that would preclude physical activity
  • Infectious illness
  • Acute inflammation (white blood count outside the normal range of 4.8-10.8 of 1000/mm3)
  • Chronic systemic inflammatory diseases (e.g., rheumatoid arthritis), or other acute illness that may affect systemic inflammation at the time of blood draw and fat tissue biopsy
  • Regularly taking high doses of oral steroid medication (more than typical basal replacement levels)
  • High doses of aspirin (above 1 g/day), or high doses of nonsteroidal anti-inflammatory drugs (e.g., 3-4 times/day)

Sites / Locations

  • Maricopa Integrated Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Madres para la Salud

Attention-control

Arm Description

Participants attended Madres para la Salud sessions in a group, led by a promotora at the Maricopa Medical Center and other community based sites. Sessions consisted of a 30 minute education and social support session where women learned to walk at least 150 minutes a week at a 20 minute-mile pace, and up to 30 minutes of moderate intensity walking with the group. Participants received an Omron pedometer and learned to monitor walking intensity. Participants set and reviewed weekly walking goals at the group sessions and recorded aerobic steps per day. After the 12 week sessions, participants met with the promotora once a week for 40 weeks, in-group, to walk at a moderate intensity for 30 minutes, to download and review pedometer data. Data was collected at baseline, 3, 6, 9 and 12 months.

Participants in the attention receive monthly brief telephone calls by research technicians and collection of study data on-site at the Maricopa Medical Center and other community based sites at baseline, 6, and 12 months (T1, T3, T5). The staff did not give advice or support specific to walking, which enabled a valid evaluation of the intervention effect. The content given to the attention-control group did not include the "active ingredients" of the Madres para la Salud intervention. The attention-control group received monthly mailings of health-related information regarding common postpartum or newborn concerns, such as breastfeeding, infant sleep, sibling rivalry, emotional support related to new parenthood, and early childhood development topics.

Outcomes

Primary Outcome Measures

Change from Baseline Body Fat Percentage at 6 months
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL). Instrument calibration was performed internally prior to each estimate of body composition. Measurement of body composition using BIA analysis followed the method outlined by Ritchie, Miller, and Smiciklas-Wright (Ritchie, Miller, & Smiciklas-Wright, 2005). A subsample of the intervention group had body fat measured with state-of-the-art dual energy x-ray absorptiometry (DEXA) at baseline and 12 months.
Change from Baseline Body Fat Percentage at 12 months
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL).
Change from Baseline Systemic and fat tissue inflammation at 12 months
Systemic and fat tissue inflammation was measured through a fat biopsy that was conducted by a trained physician (M.D.)
Change from Baseline in Edinburgh Postnatal Depression Scale at 6 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
Change from Baseline in Edinburgh Postnatal Depression Scale at 12 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.

Secondary Outcome Measures

Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months
Social Support and walking were measured through the MOS Social Support survey and the Social Support and Exercise Survey.
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months
Social Support was measured through the MOS Social Support survey and the Social Support and Exercise Survey.
Change from baseline in Neighborhood Health Questionnaire at 6 months
Environmental Factor Moderators were measured through the Neighborhood Health Questionnaire. This questionnaire includes questions relating to Neighborhood walkability, Aesthetic Quality, Safety, Social Cohesion, Violence, and Activities with neighbors.
Change from baseline in Neighborhood Health Questionnaire at 12 months
Environmental Factor Moderators were measured through the Neighborhood Health Questionnaire. This questionnaire includes questions relating to Neighborhood walkability, Aesthetic Quality, Safety, Social Cohesion, Violence, and Activities with neighbors.

Full Information

First Posted
July 19, 2013
Last Updated
July 24, 2013
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT01908959
Brief Title
Madres Para la Salud (Mothers for Health)
Official Title
Madres Para la Salud (Mothers for Health)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of "Madres Para la Salud" [Mothers for Their Health] is to see how support and encouragement can help women to make positive changes in their health. This program tested if supportive information, encouragement, and walking as a group would increase physical activity and health benefits, such as weight loss and postpartum depression. Participants in this study were randomly assigned to one of two groups, a walking or a non-walking group. The walking group met weekly. Participants were given a pedometer to record the number of steps taken daily. Participants met one time each week with our study staff. Participants walked four other days per week on their own, or with other group members. Participants measurements included body fat, waist, and hip at the beginning of the study, and at 3, 6, 9, and 12 months. The non-walking group received a weekly mailed newsletter about topics such as parenting, infant growth and development, and reproductive health. Non-walking group participants' measurements included body fat, waist, and hip at the beginning of the study and at 6 and 12 months.
Detailed Description
Project Summary The purpose of "Madres para la Salud" (Mothers for Health) was to explore the effectiveness of a culturally specific intervention using walking "bouts" to affect changes in the health of Hispanic women following childbirth. The project will advance our understanding of the relationship between moderate increases in physical activity and consequent body fat loss and decreased postpartum depression symptoms in sedentary Hispanic women during the postpartum period. This was accomplished by having a group of women who participated in supportive information and walking sessions, both alone and with study personnel, and an attention control group who received monthly phone calls to address common postpartum health concerns, but who did not participate in the walking program. Both groups received weekly health-focused newsletters with no content related to the intervention. The women had a random assignment to a group. Study Aims The purpose of this social support intervention program was to test the theory-driven Madres para la Salud with Hispanic women by conducting a formative evaluation of the intervention: Aim 1: Examine the effectiveness of the Madres para la Salud, a theoretically driven social support intervention for reducing the distal outcomes in: (a) body fat; (b) systemic and fat tissue inflammation; and (c) PPD symptoms among postpartum Hispanic women compared with an attention control group, at 6 and 12 months, after controlling for dietary intake. Aim2: Test whether the theoretical mediators, intermediate outcomes, of social support and walking, and environmental factor moderators, affect changes in body fat; systemic and fat tissue inflammation; and PPD symptoms among postpartum Hispanic women completing the Madres para la Salud intervention compared with an attention control group, at 6 and 12 months, after controlling for dietary intake. Aim 3: Determine the relationship between the immediate outcome of walking (minutes walked per week) and change in the distal outcomes of: (a) body fat; (b) systemic and fat tissue inflammation; and (c) PPD symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Depression, Postpartum, Mother (Person)
Keywords
Hispanic Women, Postpartum, Overweight Hispanic Women, Low-income, Physical Activity, Walking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Madres para la Salud
Arm Type
Experimental
Arm Description
Participants attended Madres para la Salud sessions in a group, led by a promotora at the Maricopa Medical Center and other community based sites. Sessions consisted of a 30 minute education and social support session where women learned to walk at least 150 minutes a week at a 20 minute-mile pace, and up to 30 minutes of moderate intensity walking with the group. Participants received an Omron pedometer and learned to monitor walking intensity. Participants set and reviewed weekly walking goals at the group sessions and recorded aerobic steps per day. After the 12 week sessions, participants met with the promotora once a week for 40 weeks, in-group, to walk at a moderate intensity for 30 minutes, to download and review pedometer data. Data was collected at baseline, 3, 6, 9 and 12 months.
Arm Title
Attention-control
Arm Type
No Intervention
Arm Description
Participants in the attention receive monthly brief telephone calls by research technicians and collection of study data on-site at the Maricopa Medical Center and other community based sites at baseline, 6, and 12 months (T1, T3, T5). The staff did not give advice or support specific to walking, which enabled a valid evaluation of the intervention effect. The content given to the attention-control group did not include the "active ingredients" of the Madres para la Salud intervention. The attention-control group received monthly mailings of health-related information regarding common postpartum or newborn concerns, such as breastfeeding, infant sleep, sibling rivalry, emotional support related to new parenthood, and early childhood development topics.
Intervention Type
Behavioral
Intervention Name(s)
Madres para la Salud
Intervention Description
Participants attended Madres para la Salud sessions in a group, led by a promotora at the Maricopa Medical Center and other community based sites. Sessions consisted of a 30 minute education and social support session where women learned to walk at least 150 minutes a week at a 20 minute-mile pace, and up to 30 minutes of moderate intensity walking with the group. Participants received a pedometer and learned to monitor their walking intensity. Participants set and reviewed weekly walking goals at the group sessions and recorded aerobic steps per day. After the 12 week sessions, participants met with the promotora once a week for 40 weeks of in-group walking at a moderate intensity for 30 minutes, to download and review pedometer data. Data was collected at baseline, 3, 6, 9 and 12 months.
Primary Outcome Measure Information:
Title
Change from Baseline Body Fat Percentage at 6 months
Description
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL). Instrument calibration was performed internally prior to each estimate of body composition. Measurement of body composition using BIA analysis followed the method outlined by Ritchie, Miller, and Smiciklas-Wright (Ritchie, Miller, & Smiciklas-Wright, 2005). A subsample of the intervention group had body fat measured with state-of-the-art dual energy x-ray absorptiometry (DEXA) at baseline and 12 months.
Time Frame
6 months
Title
Change from Baseline Body Fat Percentage at 12 months
Description
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL).
Time Frame
12 Months
Title
Change from Baseline Systemic and fat tissue inflammation at 12 months
Description
Systemic and fat tissue inflammation was measured through a fat biopsy that was conducted by a trained physician (M.D.)
Time Frame
12 months
Title
Change from Baseline in Edinburgh Postnatal Depression Scale at 6 months
Description
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
Time Frame
6 months
Title
Change from Baseline in Edinburgh Postnatal Depression Scale at 12 months
Description
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months
Description
Social Support and walking were measured through the MOS Social Support survey and the Social Support and Exercise Survey.
Time Frame
6 months
Title
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months
Description
Social Support was measured through the MOS Social Support survey and the Social Support and Exercise Survey.
Time Frame
12 months
Title
Change from baseline in Neighborhood Health Questionnaire at 6 months
Description
Environmental Factor Moderators were measured through the Neighborhood Health Questionnaire. This questionnaire includes questions relating to Neighborhood walkability, Aesthetic Quality, Safety, Social Cohesion, Violence, and Activities with neighbors.
Time Frame
6 months
Title
Change from baseline in Neighborhood Health Questionnaire at 12 months
Description
Environmental Factor Moderators were measured through the Neighborhood Health Questionnaire. This questionnaire includes questions relating to Neighborhood walkability, Aesthetic Quality, Safety, Social Cohesion, Violence, and Activities with neighbors.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Relationship between Walking Outcomes and listed Primary Outcomes at 6 months
Description
The relationship between walking outcomes and the previously listed primary outcomes was measured through the change in body fat and postpartum depression symptoms (at Baseline, 6 months, and 12 months), systemic and fat tissue inflammation (at Baseline and 12 months).
Time Frame
6 months
Title
Relationship between Walking Outcomes and listed Primary Outcomes at 12 months
Description
The relationship between walking outcomes and the previously listed primary outcomes was measured through the change in body fat and postpartum depression symptoms (at Baseline, 6 months, and 12 months), systemic and fat tissue inflammation (at Baseline and 12 months).
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hispanic descendent Between 18 and 40 years old At least 6-weeks but less than 6-months post childbirth Sedentary (according to the American College of Sports Medicine) Have the ability to participate in moderate intensity physical activity (according to the Physical Activity Readiness Questionnaire (PAR-Q)) Exclusion Criteria: Pregnant or planning a pregnancy in the next 12 months Have a BMI less than 25 or greater than 35 Take anti-depressant medications Take anticoagulants or herbal therapy to thin the blood Participate in regular, strenuous physical activity (exceeding 150 minutes of moderate physical activity per week) Severe musculoskeletal or cardiorespiratory problems that would preclude physical activity Infectious illness Acute inflammation (white blood count outside the normal range of 4.8-10.8 of 1000/mm3) Chronic systemic inflammatory diseases (e.g., rheumatoid arthritis), or other acute illness that may affect systemic inflammation at the time of blood draw and fat tissue biopsy Regularly taking high doses of oral steroid medication (more than typical basal replacement levels) High doses of aspirin (above 1 g/day), or high doses of nonsteroidal anti-inflammatory drugs (e.g., 3-4 times/day)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen S Keller, PhD
Organizational Affiliation
Arizona State University, College of Nursing and Health Innovation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Integrated Health System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21986392
Citation
Records K, Keller C, Ainsworth B, Permana P. Instrument selection for randomized controlled trials: why this and not that? Contemp Clin Trials. 2012 Jan;33(1):143-50. doi: 10.1016/j.cct.2011.09.006. Epub 2011 Oct 1.
Results Reference
background
PubMed Identifier
21238614
Citation
Keller C, Records K, Ainsworth B, Belyea M, Permana P, Coonrod D, Vega-Lopez S, Nagle-Williams A. Madres para la Salud: design of a theory-based intervention for postpartum Latinas. Contemp Clin Trials. 2011 May;32(3):418-27. doi: 10.1016/j.cct.2011.01.003. Epub 2011 Jan 14.
Results Reference
background
PubMed Identifier
23476752
Citation
Keller C, Todd M, Ainsworth B, Records K, Vega-Lopez S, Permana P, Coonrod D, Nagle Williams A. Overweight, obesity, and neighborhood characteristics among postpartum Latinas. J Obes. 2013;2013:916468. doi: 10.1155/2013/916468. Epub 2013 Feb 6.
Results Reference
background
PubMed Identifier
23439416
Citation
Ainsworth BE, Keller C, Herrmann S, Belyea M, Records K, Nagle-Williams A, Vega-Lopez S, Permana P, Coonrod DV. Physical activity and sedentary behaviors in postpartum Latinas: Madres para la Salud. Med Sci Sports Exerc. 2013 Jul;45(7):1298-306. doi: 10.1249/MSS.0b013e3182863de5.
Results Reference
background
PubMed Identifier
25408998
Citation
Vega-Lopez S, Pignotti GA, Keller C, Todd M, Ainsworth B, Nagle Williams A, Records K, Coonrod D, Permana P. Participation in a Social-Support Physical Activity Intervention Modestly Improves Lipoprotein Cholesterol Distribution Among Postpartum Sedentary Hispanic Women. J Phys Act Health. 2015 Sep;12(9):1289-97. doi: 10.1123/jpah.2014-0245. Epub 2014 Nov 19.
Results Reference
derived
PubMed Identifier
25233867
Citation
Keller C, Ainsworth B, Records K, Todd M, Belyea M, Vega-Lopez S, Permana P, Coonrod D, Nagle-Williams A. A comparison of a social support physical activity intervention in weight management among post-partum Latinas. BMC Public Health. 2014 Sep 19;14:971. doi: 10.1186/1471-2458-14-971.
Results Reference
derived

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Madres Para la Salud (Mothers for Health)

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