Madres Para la Salud (Mothers for Health)

Overweight and Obesity Clinical Trial

Official title:

Madres Para la Salud (Mothers for Health)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908959
• Other study ID #: 1R01NR010356-01A2
• Status: Completed
• Phase: N/A
• First received: July 19, 2013
• Last updated: July 24, 2013
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Madres para la Salud
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.

Locations

Country	Name	City	State
United States	Maricopa Integrated Health System	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ainsworth BE, Keller C, Herrmann S, Belyea M, Records K, Nagle-Williams A, Vega-López 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. — View Citation

Keller C, Records K, Ainsworth B, Belyea M, Permana P, Coonrod D, Vega-López 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between Walking Outcomes and listed Primary Outcomes at 6 months	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).	6 months	No
Other	Relationship between Walking Outcomes and listed Primary Outcomes at 12 months	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).	12 months	No
Primary	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.	6 months	No
Primary	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).	12 Months	No
Primary	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.)	12 months	No
Primary	Change from Baseline in Edinburgh Postnatal Depression Scale at 6 months	Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.	6 months	No
Primary	Change from Baseline in Edinburgh Postnatal Depression Scale at 12 months	Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.	12 months	No
Secondary	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.	6 months	Yes
Secondary	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.	12 months	Yes
Secondary	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.	6 months	Yes
Secondary	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.	12 months	Yes

External Links

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