DiabetesNCT01868230
Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
A study testing Lifestyle Intervention in people with Diabetes, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Hispanic women
- Overweight or obese before pregnancy (BMI >25 kg/m2)
- 16-45 years old
Who cannot join
- prepregnancy BMI <25 kg/m2
- history of type 2 diabetes, heart disease, or chronic renal disease
- contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)
- inability to read English or Spanish at a 6th grade level
- >16 wks gestation
- current medications which adversely influence glucose tolerance
- not planning to continue to term or deliver at the study site
- pregnant with twins or triplets
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Proyecto Mama: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.
Read the detailed description
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin), 3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4) offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and 5) to evaluate the cost-effectiveness of the intervention per average incremental improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in early pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally adapted for Hispanics and shown to be efficacious in our previous controlled trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention during pregnancy (~12 wks gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum); follow-up will continue for one year postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical activity through increasing walking and developing a more active lifestyle; and reduction in total calories by following a balanced healthy diet in compliance with American Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies for partner and/or family support to address the specific social, cultural, and economic challenges faced by underserved Hispanic women. Measures of compliance will include actigraphs and Hispanic food frequency questionnaires. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of exercise interventions among Hispanic pregnant women (R01 DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18 DK0658850) and can readily be translated into clinical practice in underserved and minority populations.
- Conditions
- Diabetes
- Being tested
- Lifestyle Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Stage-matched physical activity and diet intervention materials and health education. Receives: Behavioral: Lifestyle Intervention |
| Health and Wellness | No intervention | HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain
Gestational weight change will be measured as the difference between weight at delivery and prepregnancy weight as abstracted from the medical record. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Measured: delivery
Postpartum Weight Change
Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Percent of Participants Meeting Postpartum Weight Goals
Postpartum weight goals will be defined as a 5% reduction from prepregnancy weight. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Glucose (FG)
Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Insulin
Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Hemoglobin A1c (HbA1c)
The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Adiponectin
Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Total Leptin
Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified "two-step" sandwich-type immunoassay (R\&D Systems, Minneapolis, MN) (pg/mL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Total Cholesterol
Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Low Density Lipoprotein Cholesterol
Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
High Density Lipoprotein Cholesterol.
The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Triglycerides
Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
High Sensitivity C-Reactive Protein
The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Compliance With IOM Weight Gain Guidelines for Pregnancy.
Compliance with IOM weight gain guidelines during pregnancy is measured by comparing the observed gestational weight gain (GWG) with the 2009 IOM Guidelines. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing weights were imputed in the manner of prior trials with the use of 10 random multivariate imputations based on observed variables at baseline. Total GWG was calculated by subtracting pre-pregnancy weight from weight at delivery and was categorized as "below," "within," or "above" IOM guidelines based on the IOM's 2009 GWG guidelines: specifically, women with an underweight BMI are advised to gain a total of 28-40 lbs, women with a BMI in the normal weight category are advised to gain 25-35 lbs., women with a BMI in the overweight category are advised to gain 15-25 lbs, and women with a BMI in the obese category are advised to gain 11-20 lbs.
Measured: delivery
Child Waist Circumference
measuring tape
Measured: delivery
Child Head Circumference
measuring tape
Measured: delivery
Child Skinfold Thicknesses - Subcapsular and Triceps
calipers
Measured: delivery
Fetal Growth
Birthweight-for-gestational age z-scores will be calculated by subtracting the mean and dividing by the standard deviation from a standardization population (specifically, the 2014 Natality data from National Center for Health Statistics using data limited to Hispanic ethnicity). A Z-score of 0 represents the population mean. Z score values <0 represent scores lower than the population average observed in the standardization population. It remains to be established which z score range (percentile and SD) is associated with optimal short- and long-term offspring health.
Measured: delivery
Ponderal Index
The ponderal index is calculated as birth weight (g) x 100/birth length (cm). A lower ponderal index is typically used to identify neonates that were affected by intrauterine growth restriction. For example, ponderal indexes between 2.5 and 3.0 are generally considered normal, between 2.0 and 2.5 marginal, and less than 2.0 low (unhealthy).
Measured: delivery
Birthweight
scale
Measured: delivery
Child Length
measuring tape
Measured: delivery
Secondary outcomes (1)
Physical Activity
Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ). The American College of Gynecologists (ACOG) recommend that pregnant women obtain at least 30 minutes of moderate-intensity PA on most days of the week during pregnancy and postpartum. Therefore, meeting ACOG guidelines will be defined as women who obtain at least 150 minutes of moderate to vigorous intensity activity during exercise.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2014
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, San Diego, Northeastern University, Baystate Medical Center
- Responsible party
- Principal investigator, Lisa Chasan-Taber, University of Massachusetts, Amherst
- Investigators
- Lisa Chasan-Taber, ScD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868230
- Sponsor's protocol ID
- 1R01DK097011-01A1
- Other IDs
- 1R01DK097011-01A1
- Status last verified
- Feb 2026
- First submitted
- 29 May 2013
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x.
PubMed 31170973Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Stanek E 3rd, Braun B, Solomon CG, Manson JE, Goff SL, Markenson G. Proyecto Mama: a lifestyle intervention in overweight and obese Hispanic women: a randomised controlled trial--study protocol. BMC Pregnancy Childbirth. 2015 Jul 30;15:157. doi: 10.1186/s12884-015-0575-3.
PubMed 26223246
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proyecto Mama: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
- ClinicalTrials.gov ID
- NCT01868230
- Acronym / sponsor ID
- 1R01DK097011-01A1
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, San Diego, Northeastern University, Baystate Medical Center
- Study start
- Jun 2014
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.
Detailed description
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin), 3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4) offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and 5) to evaluate the cost-effectiveness of the intervention per average incremental improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in early pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally adapted for Hispanics and shown to be efficacious in our previous controlled trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention during pregnancy (~12 wks gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum); follow-up will continue for one year postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical activity through increasing walking and developing a more active lifestyle; and reduction in total calories by following a balanced healthy diet in compliance with American Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies for partner and/or family support to address the specific social, cultural, and economic challenges faced by underserved Hispanic women. Measures of compliance will include actigraphs and Hispanic food frequency questionnaires. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of exercise interventions among Hispanic pregnant women (R01 DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18 DK0658850) and can readily be translated into clinical practice in underserved and minority populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionStage-matched physical activity and diet intervention materials and health education. |
| Health and Wellness | No intervention | –HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Hispanic women
- Overweight or obese before pregnancy (BMI >25 kg/m2)
- 16-45 years old
Key exclusion criteria (8 listed)
- prepregnancy BMI <25 kg/m2
- history of type 2 diabetes, heart disease, or chronic renal disease
- contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)
- inability to read English or Spanish at a 6th grade level
- >16 wks gestation
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 |
|---|---|---|
| Lifestyle Intervention | Behavioural | Lifestyle Intervention |
Primary outcome
Gestational Weight Gain
Time frame: delivery
Gestational weight change will be measured as the difference between weight at delivery and prepregnancy weight as abstracted from the medical record. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Postpartum Weight Change
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Percent of Participants Meeting Postpartum Weight Goals
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Postpartum weight goals will be defined as a 5% reduction from prepregnancy weight. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Fasting Glucose (FG)
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Fasting Insulin
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Hemoglobin A1c (HbA1c)
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Adiponectin
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Total Leptin
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified "two-step" sandwich-type immunoassay (R\&D Systems, Minneapolis, MN) (pg/mL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Total Cholesterol
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Low Density Lipoprotein Cholesterol
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
High Density Lipoprotein Cholesterol.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Triglycerides
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
High Sensitivity C-Reactive Protein
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Compliance With IOM Weight Gain Guidelines for Pregnancy.
Time frame: delivery
Compliance with IOM weight gain guidelines during pregnancy is measured by comparing the observed gestational weight gain (GWG) with the 2009 IOM Guidelines. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing weights were imputed in the manner of prior trials with the use of 10 random multivariate imputations based on observed variables at baseline. Total GWG was calculated by subtracting pre-pregnancy weight from weight at delivery and was categorized as "below," "within," or "above" IOM guidelines based on the IOM's 2009 GWG guidelines: specifically, women with an underweight BMI are advised to gain a total of 28-40 lbs, women with a BMI in the normal weight category are advised to gain 25-35 lbs., women with a BMI in the overweight category are advised to gain 15-25 lbs, and women with a BMI in the obese category are advised to gain 11-20 lbs.
Child Waist Circumference
Time frame: delivery
measuring tape
Child Head Circumference
Time frame: delivery
measuring tape
Child Skinfold Thicknesses - Subcapsular and Triceps
Time frame: delivery
calipers
Fetal Growth
Time frame: delivery
Birthweight-for-gestational age z-scores will be calculated by subtracting the mean and dividing by the standard deviation from a standardization population (specifically, the 2014 Natality data from National Center for Health Statistics using data limited to Hispanic ethnicity). A Z-score of 0 represents the population mean. Z score values <0 represent scores lower than the population average observed in the standardization population. It remains to be established which z score range (percentile and SD) is associated with optimal short- and long-term offspring health.
Ponderal Index
Time frame: delivery
The ponderal index is calculated as birth weight (g) x 100/birth length (cm). A lower ponderal index is typically used to identify neonates that were affected by intrauterine growth restriction. For example, ponderal indexes between 2.5 and 3.0 are generally considered normal, between 2.0 and 2.5 marginal, and less than 2.0 low (unhealthy).
Birthweight
Time frame: delivery
scale
Child Length
Time frame: delivery
measuring tape
1 secondary outcome
Physical Activity
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31170973Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x.
- Derived from this study: PubMed 26223246Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Stanek E 3rd, Braun B, Solomon CG, Manson JE, Goff SL, Markenson G. Proyecto Mama: a lifestyle intervention in overweight and obese Hispanic women: a randomised controlled trial--study protocol. BMC Pregnancy Childbirth. 2015 Jul 30;15:157. doi: 10.1186/s12884-015-0575-3.
- Individual participant dataSharing planned: No
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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.
Lisa Chasan-Taber, ScD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Diabetes, run by University of Massachusetts, Amherst 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 3 inclusion and 8 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 24 Feb 2026. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gestational Weight Gain (time frame: delivery). The study lists 21 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 NCT01868230, which also lists 2 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 24 Feb 2026.