Clinical trial NCT01908959: Madres Para la Salud (Mothers for Health)
Official title: Madres Para la Salud (Mothers for Health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Depression, Postpartum
Mother (Person)
Keywords: Hispanic Women
Postpartum
Overweight Hispanic Women
Low-income
Physical Activity
Walking
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 177
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Change from Baseline Body Fat Percentage at 6 months
timeFrame: 6 months
measure: Change from Baseline Body Fat Percentage at 12 months
timeFrame: 12 Months
measure: Change from Baseline Systemic and fat tissue inflammation at 12 months
timeFrame: 12 months
measure: Change from Baseline in Edinburgh Postnatal Depression Scale at 6 months
timeFrame: 6 months
measure: Change from Baseline in Edinburgh Postnatal Depression Scale at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months
timeFrame: 6 months
measure: Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months
timeFrame: 12 months
measure: Change from baseline in Neighborhood Health Questionnaire at 6 months
timeFrame: 6 months
measure: Change from baseline in Neighborhood Health Questionnaire at 12 months
timeFrame: 12 months
Other outcomes:
measure: Relationship between Walking Outcomes and listed Primary Outcomes at 6 months
timeFrame: 6 months
measure: Relationship between Walking Outcomes and listed Primary Outcomes at 12 months
timeFrame: 12 months
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
Study officials:
affiliation: Arizona State University, College of Nursing and Health Innovation
name: Colleen S Keller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.