Madres Para la Salud (Mothers for Health)

NCT01908959 | Completed

• 1 other identifier: 1R01NR010356-01A2
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hispanic Women; Postpartum; Overweight Hispanic Women; Low-income; Physical Activity; Walking

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months

  6 months

• Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months

  12 months

• Change from baseline in Neighborhood Health Questionnaire at 6 months

  6 months

• Change from baseline in Neighborhood Health Questionnaire at 12 months

  12 months

Other Outcomes (2)

• Relationship between Walking Outcomes and listed Primary Outcomes at 6 months

  6 months

• Relationship between Walking Outcomes and listed Primary Outcomes at 12 months

  12 months

Study Arms (2)

Madres para la Salud

EXPERIMENTAL

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.

Behavioral: Madres para la Salud

Attention-control

NO INTERVENTION

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.

Interventions

Madres para la Salud BEHAVIORAL

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.

Madres para la Salud

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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))

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

Location

Related Publications (6)

• 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.

  PMID: 21986392 BACKGROUND

• 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.

  PMID: 21238614 BACKGROUND

• 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.

  PMID: 23476752 BACKGROUND

• 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.

  PMID: 23439416 BACKGROUND

• 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.

  PMID: 25408998 DERIVED

• 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.

  PMID: 25233867 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Depression, Postpartum; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Study Officials

• Colleen S Keller, PhD

  Arizona State University, College of Nursing and Health Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colleen Keller, PhD, RN-C, FNP, FAHA, FNAP

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 26, 2013
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

US (1)