Overweight and ObesityNCT01908959
Madres Para la Salud (Mothers for Health)
A study testing Madres para la Salud in people with Overweight and Obesity and Depression, Postpartum, run by Arizona State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Depression, Postpartum, Mother (Person)
- What is being tested?
- Madres para la Salud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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))
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Maricopa Integrated Health System
Phoenix, Arizona, 85008
About this study
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.
Read the 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.
- Being tested
- Madres para la Salud
- Keywords
- Hispanic Women, Postpartum, Overweight Hispanic Women, Low-income, Physical Activity, Walking
- Medical subject headings
- Overweight, Obesity, Depression, Postpartum, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Madres para la SaludBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.)
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 6 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Keller, Arizona State University
- Investigators
- Colleen S Keller, PhD, Principal investigator, Arizona State University, College of Nursing and Health Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908959
- Sponsor's protocol ID
- 1R01NR010356-01A2
- Status last verified
- Jul 2013
- First submitted
- 19 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21986392Keller 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.
PubMed 21238614Keller 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.
PubMed 23476752Ainsworth 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.
PubMed 23439416Vega-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.
PubMed 25408998Keller 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.
PubMed 25233867
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Madres Para la Salud (Mothers for Health)
- ClinicalTrials.gov ID
- NCT01908959
- Acronym / sponsor ID
- 1R01NR010356-01A2
- Keywords
- Hispanic Women, Postpartum, Overweight Hispanic Women, Low-income, Physical Activity, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Madres para la Salud | Experimental | Behavioral: Madres para la SaludParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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))
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Madres para la SaludParticipants 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. | Behavioural | Madres para la Salud |
Primary outcome
Change from Baseline Body Fat Percentage at 6 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
4 secondary outcomes
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months
Time frame: 6 months
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months
Time frame: 12 months
Change from baseline in Neighborhood Health Questionnaire at 6 months
Time frame: 6 months
Change from baseline in Neighborhood Health Questionnaire at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
- Background: PubMed 21986392Records 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.
- Background: PubMed 21238614Keller 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.
- Background: PubMed 23476752Keller 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.
- Background: PubMed 23439416Ainsworth 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.
- Derived from this study: PubMed 25408998Vega-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.
- Derived from this study: PubMed 25233867Keller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen S Keller, PhD principal investigator
Arizona State University, College of Nursing and Health Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Madres para la Salud in people with Overweight and Obesity and Depression, Postpartum, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Body Fat Percentage at 6 months (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908959, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.