Body Weight ChangesNCT02657577

REseArCH INteGration in Women, Infants, and Children

An observational study of Body Weight Changes, run by Pennington Biomedical Research Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

WIC is a governmental program that provides healthy foods, nutrition education and referrals to other health and social services. With the goal of applying for a future grant to expand the dissemination of SmartLoss® within the WIC program, feedback from WIC staff and WIC clients must be solicited to better understand… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Body Weight Changes
How many people: 628 participants
Where: No sites listed yet
Study dates: 3 Feb 2016to 2 Jun 2016
Phase: Observational
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Up to 1000 individuals will be identified at WIC clinics in Louisiana. Participants must be at least 18 years of age.

Who may be able to join

Individuals who are at least 18 years old
Have been employed or volunteered at a WIC Clinic or DHH in Louisiana for at least 6 months in the past 2 years OR received WIC services during pregnancy or postpartum or have had a child who received WIC services in the past 2 years

Who cannot join

Less than 18 years old

About this study

Official title: REseArCH INteGration in Women, Infants, and Children: REACHING WIC

Read the detailed description

Participants will complete a 15 minute online survey. WIC Staff will be eligible to complete the WIC staff survey and WIC clients will be eligible to complete the WIC client survey. This is a qualitative research study designed to identify the receptiveness of implementing a weight management program in the WIC program and the barriers to weight management intervention as described by WIC staff and WIC clients.

Conditions: Body Weight Changes
Being tested: There is no intervention
Keywords: Women, Infants and Children, Survey
Medical subject headings: Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

There is no interventionOther
There is no intervention

Study groups in NCT02657577
Study group	Role	What they receive
WIC staff		WIC staff is eligible to complete the WIC staff online survey if the individual is at least 18 years of age and have been employed at a WIC Clinic or DHH in Louisiana for at least 6 months in the past 2 years. Receives: Other: There is no intervention
WIC clients		WIC client is eligible to complete the WIC client online survey if the individual is at least 18 years of age and received WIC services during pregnancy or postpartum or have had a child who received WIC services in the past 2 years. Receives: Other: There is no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Receptiveness to Weight Management Interventions in the WIC Program
WIC staff and WIC clients were asked if they were receptive to implementing weight management interventions in the WIC program with answer options: Yes, No, Neutral, or Unanswered.
Measured: 1 day
Barriers to WIC Appointments as Described by WIC Clients
WIC clients were asked what are barriers that they experience attending their WIC appointments.
Measured: 1 day
Lack of Time at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
WIC staff were asked to choose the how they feel about lack of time as a barrier to implementing weight management interventions at WIC appointments.
Measured: 1 day
Lack of Staff at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
WIC staff were asked to choose the how they feel about lack of staff as a barrier to implementing weight management interventions at WIC appointments.
Measured: 1 day
Lack of Training at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
WIC staff were asked to choose the how they feel about lack of training as a barrier to implementing weight management interventions at WIC appointments.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 20162 Jun 2016

First posted18 Jan 2016 (estimated)
Study start3 Feb 2016
Primary completion2 Jun 2016
Study completion2 Jun 2016

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 Body Weight ChangesStudies 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: Observational
Observational model: Ecologic or community
Time perspective: Other
Enrolment: 628 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02657577
Sponsor's protocol ID: PBRC 2014-048
Status last verified: Sep 2022
First submitted: 14 Jan 2016
Last updated: 8 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Metabolic Health, Bones and Nuts During Weight Loss in Adults
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A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
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Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight

All Body Weight Changes trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REseArCH INteGration in Women, Infants, and Children: REACHING WIC
ClinicalTrials.gov ID: NCT02657577
Acronym / sponsor ID: PBRC 2014-048
Conditions: Body Weight Changes
Keywords: Women, Infants and Children, Survey
Study type: Observational
Recruitment status: Completed
Enrolment: 628 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Study start: 3 Feb 2016 (actual)
Primary completion: 2 Jun 2016 (actual)
Study completion: 2 Jun 2016 (actual)
First posted: 18 Jan 2016 (estimated)
Results: Posted 8 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Ecologic or community
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
WIC staff	–	Other: There is no interventionWIC staff is eligible to complete the WIC staff online survey if the individual is at least 18 years of age and have been employed at a WIC Clinic or DHH in Louisiana for at least 6 months in the past 2 years.
WIC clients	–	Other: There is no interventionWIC client is eligible to complete the WIC client online survey if the individual is at least 18 years of age and received WIC services during pregnancy or postpartum or have had a child who received WIC services in the past 2 years.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Up to 1000 individuals will be identified at WIC clinics in Louisiana. Participants must be at least 18 years of age.

Key inclusion criteria (2 listed)

Individuals who are at least 18 years old
Have been employed or volunteered at a WIC Clinic or DHH in Louisiana for at least 6 months in the past 2 years OR received WIC services during pregnancy or postpartum or have had a child who received WIC services in the past 2 years

Key exclusion criteria (1 listed)

Less than 18 years old

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
There is no interventionThere is no intervention	Other	WIC clients, WIC staff

Primary outcome

Receptiveness to Weight Management Interventions in the WIC Program
Time frame: 1 day
WIC staff and WIC clients were asked if they were receptive to implementing weight management interventions in the WIC program with answer options: Yes, No, Neutral, or Unanswered.
Barriers to WIC Appointments as Described by WIC Clients
Time frame: 1 day
WIC clients were asked what are barriers that they experience attending their WIC appointments.
Lack of Time at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
Time frame: 1 day
WIC staff were asked to choose the how they feel about lack of time as a barrier to implementing weight management interventions at WIC appointments.
Lack of Staff at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
Time frame: 1 day
WIC staff were asked to choose the how they feel about lack of staff as a barrier to implementing weight management interventions at WIC appointments.
Lack of Training at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
Time frame: 1 day
WIC staff were asked to choose the how they feel about lack of training as a barrier to implementing weight management interventions at WIC appointments.

Results and safety

Results posted to the registry on 8 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WIC Staff	201	164
WIC Clients	427	383

Primary outcome: Receptiveness to Weight Management Interventions in the WIC Program

Time frame: 1 day. Count of participants. Unit: Participants

Measure	WIC Staff n = 164	WIC Clients n = 383
Yes	126	184
No	6	190
Neutral	30	0
Unanswered	2	9

Primary outcome: Barriers to WIC Appointments as Described by WIC Clients

Time frame: 1 day. Count of participants. Unit: Participants

Measure	WIC Staff n = 0	WIC Clients n = 383
No barriers	–	314
Lack of time	–	33
Lack of transportation	–	32
Unanswered	–	4

Population analysed: This question was only asked as part of the WIC clients survey as it dealt directly with barriers that WIC Clients experience.

Primary outcome: Lack of Time at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff

Time frame: 1 day. Count of participants. Unit: Participants

Measure	WIC Staff n = 164	WIC Clients n = 0
Strongly Disagree	5	–
Disagree	4	–
Neither Disagree or Agree	19	–
Agree	71	–
Strongly Agree	61	–
Unanswered	4	–

Population analysed: This question was only asked as part of the WIC staff survey as it dealt directly with barriers that WIC Staff experience.

Primary outcome: Lack of Staff at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff

Time frame: 1 day. Count of participants. Unit: Participants

Measure	WIC Staff n = 164	WIC Clients n = 0
Strongly Disagree	8	–
Disagree	13	–
Neither Disagree or Agree	33	–
Agree	58	–
Strongly Agree	47	–
Unanswered	5	–

Population analysed: This question was only asked as part of the WIC staff survey as it dealt directly with barriers that WIC staff experience.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WIC Staff	0 of 0	0 of 0	Not reported
WIC Clients	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Completeness checks were not used.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Body Weight Changes

Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Body Weight Changes, run by Pennington Biomedical Research Center.

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 2 inclusion and 1 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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 8 Aug 2023). 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?

Receptiveness to Weight Management Interventions in the WIC Program (time frame: 1 day). 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 NCT02657577.

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 8 Aug 2023.