Weight LossNCT03257657
Helping Moms to be Healthy After Baby
A study testing Observation Group participants and Lifestyle group participants in people with Weight Loss and Diet Modification, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Diet Modification, Obesity
- What is being tested?
- Observation Group participants and Lifestyle group participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2017to 22 Feb 2018
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult woman (≥18 and <50 years old).
- Enrolled in WIC or with an infant enrolled in WIC.
- 3-12 months postpartum.
- A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to pregnancy).
- Postpartum body mass index between 25 and 50 kg/m2.
- English- and/or Spanish-speaking.
- Owns a mobile phone with texting functionality in order to receive texts during the trial.
Who cannot join
- Health conditions impacting weight or ability to participate in a weight loss trial.
- Pregnancy or planned pregnancy in next 5 months.
- Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise.
- Medical provider recommendation to avoid exercise.
- Plans to be in a different geographic area within the next 5 months.
- Plans to stop coming to Aurora WIC in the next 5 months.
Show all 10Show fewer
- Unable to give informed consent.
- Not able to read and understand English or Spanish at an 8th grade level.
- Not willing to create a Facebook account if they do not already have one.
- Asked to follow-up in < 3 months at most recent WIC visit.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aurora WIC Office
Aurora, Colorado, 80011
University of Colorado
Aurora, Colorado, 80045
About this study
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:
Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.
Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.
Read the detailed description
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.
Obesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.
- Conditions
- Weight Loss, Diet Modification, Obesity
- Being tested
- Observation Group participants, Lifestyle group participants
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation Group participantsBehavioural
Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.
Lifestyle group participantsBehavioural
Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | Experimental | Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. Receives: Behavioral: Observation Group participants |
| Lifestyle Group | Experimental | Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. Receives: Behavioral: Lifestyle group participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment
Measured: Once the final participant is recruited
Attrition Rate of Subjects Enrolled in the Study
The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
Measured: Once the final participant completes the 12 week visit
Visit Attendance
The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported
Measured: Baseline through Week 12, reported at Week 12
Acceptability of a Weight Loss Intervention
To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.
Measured: 12 weeks
Evaluation of the Use of Phone Coaching
Investigators will count the total number of times any participant used phone coaching.
Measured: 12 weeks
Secondary outcomes (8)
Change in Weight Between Visits
To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.
Measured: Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks
Changes in Diet: Intakes Measured in Grams
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
Measured: Baseline and 12 weeks
Changes in Physical Activity
To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.
Measured: Baseline and 12 weeks
Changes in Diet and Physical Activity Self-efficacy
To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.
Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.
Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.
Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.
Measured: Baseline and 12 weeks
Changes in Motivations to Eat
To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.
Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.
Measured: Baseline and 12 weeks
Changes in Readiness to Change
Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change
Measured: Baseline and 12 weeks
Changes in Diet: Intakes Measured in Cups
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.
Measured: Baseline and 12 weeks
Changes in Diet: kCal Intake
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start31 Jul 2017
- Primary completion22 Feb 2018
- Study completion22 Feb 2018
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.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Darcy A Thompson, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257657
- Sponsor's protocol ID
- 16-1932
- Other IDs
- UL1TR002535
- Status last verified
- Mar 2020
- First submitted
- 1 Aug 2017
- Last updated
- 20 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Moms to be Healthy After Baby
- ClinicalTrials.gov ID
- NCT03257657
- Acronym / sponsor ID
- 16-1932
- Conditions
- Weight Loss, Diet Modification, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 20 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:
Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.
Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.
Detailed description
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.
Obesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.
| Arm | Type | Receives |
|---|---|---|
| Observational Group | Experimental | Behavioral: Observation Group participantsIntervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit. |
| Lifestyle Group | Experimental | Behavioral: Lifestyle group participantsIntervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult woman (≥18 and <50 years old).
- Enrolled in WIC or with an infant enrolled in WIC.
- 3-12 months postpartum.
- A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to pregnancy).
- Postpartum body mass index between 25 and 50 kg/m2.
Key exclusion criteria (10 listed)
- Health conditions impacting weight or ability to participate in a weight loss trial.
- Pregnancy or planned pregnancy in next 5 months.
- Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise.
- Medical provider recommendation to avoid exercise.
- Plans to be in a different geographic area within the next 5 months.
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 |
|---|---|---|
| Observation Group participantsWomen in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time. | Behavioural | Observational Group |
| Lifestyle group participantsWomen in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks. | Behavioural | Lifestyle Group |
Primary outcome
Feasibility of Recruitment
Time frame: Once the final participant is recruited
The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment
Attrition Rate of Subjects Enrolled in the Study
Time frame: Once the final participant completes the 12 week visit
The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
Visit Attendance
Time frame: Baseline through Week 12, reported at Week 12
The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported
Acceptability of a Weight Loss Intervention
Time frame: 12 weeks
To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.
Evaluation of the Use of Phone Coaching
Time frame: 12 weeks
Investigators will count the total number of times any participant used phone coaching.
8 secondary outcomes
Change in Weight Between Visits
Time frame: Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks
Changes in Diet: Intakes Measured in Grams
Time frame: Baseline and 12 weeks
Changes in Physical Activity
Time frame: Baseline and 12 weeks
Changes in Diet and Physical Activity Self-efficacy
Time frame: Baseline and 12 weeks
Changes in Motivations to Eat
Time frame: Baseline and 12 weeks
Changes in Readiness to Change
Time frame: Baseline and 12 weeks
Changes in Diet: Intakes Measured in Cups
Time frame: Baseline and 12 weeks
Changes in Diet: kCal Intake
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Darcy A Thompson, MD, MPH principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation Group participants and Lifestyle group participants in people with Weight Loss and Diet Modification, run by University of Colorado, Denver at 2 sites 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 7 inclusion and 10 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 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 20 Mar 2020). 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?
Feasibility of Recruitment (time frame: Once the final participant is recruited). 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?
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 20 Mar 2020.