ObesitySTRIVENCT06116149
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
A study testing In-person health coach delivery of the GLB and Technology-assisted health coach delivery of the GLB in people with Obesity and Gestational Diabetes, run by Tulane University at 1 site in United States.
Trial summary
The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Gestational Diabetes, Lifestyle, Healthy
- What is being tested?
- In-person health coach delivery of the GLB and Technology-assisted health coach delivery of the GLB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Serve a large number of WIC postpartum participants
- Willing and able to provide space for the study
- Age 18 or older
- Gave birth in the past 6 weeks to 12 months
- Obesity or history of gestational diabetes mellitus (Current BMI ≥30 kg/m², OR Medical-record documented history of gestational diabetes mellitus and BMI ≥25 kg/m²)
- No self-reported diabetes (other than gestational diabetes)
Show all 13Show fewer
- Hemoglobin A1c <6.5%
- Not currently pregnant or planning to become pregnant in the next 6 months
- No plans to move outside of the study region in the next 12 months
- Access to a smartphone
- Willing and able to participate in the intervention and provide consent
- Not an immediate family member of the staff at the WIC clinic
- Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University School of Public Health and Tropical Medicine
New Orleans, Louisiana, 70112
About this study
Official title: Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial
The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.
Read the detailed description
The overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the Diabetes Prevention Program (DPP) in postpartum women who receive services from WIC. In this effectiveness-implementation type III cluster-randomized trial, we will compare two implementation strategies for DPP delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools).
Nineteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 19 to the in-person health coach-led strategy. A total of 722 postpartum participants (19 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. A post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.
- Conditions
- Obesity, Gestational Diabetes, Lifestyle, Healthy, Glucose Intolerance During Pregnancy, PreDiabetes, Hyperglycemia
- Being tested
- In-person health coach delivery of the GLB, Technology-assisted health coach delivery of the GLB
- Keywords
- Diabetes Prevention Program
- Medical subject headings
- Obesity, Diabetes, Gestational, Prediabetic State, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person health coach delivery of the GLBBehavioural
Delivery of 24 health coaching sessions in-person by health coaches over 1 year.
Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.
Technology-assisted health coach delivery of the GLBBehavioural
Delivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection.
The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.
| Study group | Role | What they receive |
|---|---|---|
| In-person health coach strategy | Active comparator | Delivery of 24 health coaching sessions in-person by health coaches over 1 year.
Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. Receives: Behavioral: In-person health coach delivery of the GLB |
| Multifaceted technology-assisted health coach implementation strategy | Active comparator | Delivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection.
The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. Receives: Behavioral: Technology-assisted health coach delivery of the GLB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in uptake (primary implementation outcome)
The primary implementation outcome will be the difference between study arms in a composite uptake score, as defined by a composite score consisting of the percent of sessions attended and the percentage of times in which participants record weight, activity, and diet compared to what is recommended by the intervention.
Measured: Measured from baseline to 12 months
Difference in mean 12-month weight reduction (primary health-related outcome)
The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms
Measured: Measured at 3, 6, 9 and 12 months
Secondary outcomes (21)
Fidelity
Percentage of sessions held
Measured: 12 months
Acceptability
Acceptability scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.
Measured: Measured at baseline, 6, and 12 months
Appropriateness
Appropriateness scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.
Measured: baseline
Feasibility (suitability)
Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome.
Measured: Baseline
Adoption (WIC clinics)
Percentage of invited WIC clinics adopting the DPP program. Measured by study administrative data.
Measured: Baseline
Adoption (WIC nutritionists)
Percentage of invited WIC nutritionists being trained. Measured by study administrative data.
Measured: Baseline
Adoption (WIC health educators)
Percentage of invited WIC health educators being trained. Measured by study administrative data.
Measured: Baseline
Penetrance (participants)
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.
Measured: 12 months
Penetrance (WIC DPP coordinators)
Percentage of percentage of trained WIC DPP coordinators supporting health coaches. Measured by study administrative data.
Measured: 12 months
Penetrance (WIC health coaches)
Percentage of percentage of trained WIC DPP health coaches delivering the intervention. Measured by study administrative data.
Measured: 12 months
Percentage of participants who were either eligible, screened, or contacted who were enrolled.
Reach
Measured: Baseline
Cost-effectiveness
Incremental direct costs (intervention) per additional percentage of individuals reaching weight loss goal at 12 months
Measured: 12 months
Difference in mean 12-month change in percent weight reduction
Difference in mean percent weight reduction from baseline to 12 months between study arms
Measured: Measured from baseline to 12 months
Difference in mean 12-month change in physical activity
Difference in mean change in physical activity from baseline to 12 months between study arms, as assessed by metabolic equivalent (MET)-h/week (measured by validated questionnaire)
Measured: Measured from baseline to 12 months
Difference in mean 12-month change in healthy eating index
Difference in mean change in healthy eating index from baseline to 12 months between study arms, as assessed by 24-hour dietary recalls (range 0 to 100; higher scores mean healthier eating pattern)
Measured: Measured from baseline to 12 months
Difference in mean 12-month change in waist circumference
Difference in mean change in waist circumference from baseline to 12 months between study arms
Measured: Measured from baseline to 12 months
Difference in mean 12-month change in hemoglobin A1c
Difference in mean change in hemoglobin A1c from baseline to 12 months between study arms
Measured: Measured from baseline to 12 months
Difference in mean 12-month change in systolic blood pressure
Difference in mean change in systolic blood pressure from baseline to 12 months between study arms
Measured: Measured from baseline to 12 months
Difference in mean 12-month change in diastolic blood pressure
Difference in mean change in diastolic blood pressure from baseline to 12 months between study arms
Measured: Measured from baseline to 12 months
Difference in mean 12-month change in health-related quality of life (HRQoL)
Difference in mean change in health-related quality of life (HRQoL) from baseline to 12 months between study arms (assessed by short form (SF)-12, validated survey)
Measured: Measured from baseline to 12 months
Difference in proportion of participants meeting intervention goals at 12 months
Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements
Measured: Measured from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start12 Dec 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomization of 38 Women, Infants, and Children (WIC) clinics
- Masking
- None (open label)
- Enrolment
- 722 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pennington Biomedical Research Center, University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116149
- Sponsor's protocol ID
- 2022-1294
- Other IDs
- OT2HL158287
- Acronym
- STRIVE
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be implemented in a timely manner. Study data, including data from baseline and follow-up visits, will be prepared sharing. Data will be prepared by the study data manager/biostatistician. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." We are very open to sharing data enthusiastically with the general scientific community, since we also believe in the added value of other investigators working on these data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06116149
- Acronym / sponsor ID
- STRIVE / 2022-1294
- Conditions
- Obesity, Gestational Diabetes, Lifestyle, Healthy, Glucose Intolerance During Pregnancy, PreDiabetes, Hyperglycemia
- Keywords
- Diabetes Prevention Program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 722 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pennington Biomedical Research Center, University of Pennsylvania
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Nov 2023 (actual)
- 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 primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.
Detailed description
The overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the Diabetes Prevention Program (DPP) in postpartum women who receive services from WIC. In this effectiveness-implementation type III cluster-randomized trial, we will compare two implementation strategies for DPP delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools).
Nineteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 19 to the in-person health coach-led strategy. A total of 722 postpartum participants (19 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. A post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomization of 38 Women, Infants, and Children (WIC) clinics
| Arm | Type | Receives |
|---|---|---|
| In-person health coach strategy | Active comparator | Behavioral: In-person health coach delivery of the GLBDelivery of 24 health coaching sessions in-person by health coaches over 1 year. Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. |
| Multifaceted technology-assisted health coach implementation strategy | Active comparator | Behavioral: Technology-assisted health coach delivery of the GLBDelivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Serve a large number of WIC postpartum participants
- Willing and able to provide space for the study
- Age 18 or older
- Gave birth in the past 6 weeks to 12 months
- Obesity or history of gestational diabetes mellitus (Current BMI ≥30 kg/m², OR Medical-record documented history of gestational diabetes mellitus and BMI ≥25 kg/m²)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| In-person health coach delivery of the GLBDelivery of 24 health coaching sessions in-person by health coaches over 1 year. Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. | Behavioural | In-person health coach strategy |
| Technology-assisted health coach delivery of the GLBDelivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight. | Behavioural | Multifaceted technology-assisted health coach implementation strategy |
Primary outcome
Difference in uptake (primary implementation outcome)
Time frame: Measured from baseline to 12 months
The primary implementation outcome will be the difference between study arms in a composite uptake score, as defined by a composite score consisting of the percent of sessions attended and the percentage of times in which participants record weight, activity, and diet compared to what is recommended by the intervention.
Difference in mean 12-month weight reduction (primary health-related outcome)
Time frame: Measured at 3, 6, 9 and 12 months
The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms
21 secondary outcomes
Fidelity
Time frame: 12 months
Acceptability
Time frame: Measured at baseline, 6, and 12 months
Appropriateness
Time frame: baseline
Feasibility (suitability)
Time frame: Baseline
Adoption (WIC clinics)
Time frame: Baseline
Adoption (WIC nutritionists)
Time frame: Baseline
Adoption (WIC health educators)
Time frame: Baseline
Penetrance (participants)
Time frame: 12 months
Penetrance (WIC DPP coordinators)
Time frame: 12 months
Penetrance (WIC health coaches)
Time frame: 12 months
Percentage of participants who were either eligible, screened, or contacted who were enrolled.
Time frame: Baseline
Cost-effectiveness
Time frame: 12 months
Difference in mean 12-month change in percent weight reduction
Time frame: Measured from baseline to 12 months
Difference in mean 12-month change in physical activity
Time frame: Measured from baseline to 12 months
Difference in mean 12-month change in healthy eating index
Time frame: Measured from baseline to 12 months
Difference in mean 12-month change in waist circumference
Time frame: Measured from baseline to 12 months
Difference in mean 12-month change in hemoglobin A1c
Time frame: Measured from baseline to 12 months
Difference in mean 12-month change in systolic blood pressure
Time frame: Measured from baseline to 12 months
Difference in mean 12-month change in diastolic blood pressure
Time frame: Measured from baseline to 12 months
Difference in mean 12-month change in health-related quality of life (HRQoL)
Time frame: Measured from baseline to 12 months
Difference in proportion of participants meeting intervention goals at 12 months
Time frame: Measured from baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be implemented in a timely manner. Study data, including data from baseline and follow-up visits, will be prepared sharing. Data will be prepared by the study data manager/biostatistician. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." We are very open to sharing data enthusiastically with the general scientific community, since we also believe in the added value of other investigators working on these data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person health coach delivery of the GLB and Technology-assisted health coach delivery of the GLB in people with Obesity and Gestational Diabetes, run by Tulane 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 13 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference in uptake (primary implementation outcome) (time frame: Measured from baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.