Weight LossNCT02251587
The $Ensible Weight Program: An Intervention Tailored for Low Income Women
A study testing Standard Weight Management Program and Sensible Weigh Program in people with Weight Loss, run by Jeannine Goetz, PhD at 1 site in United States.
Trial summary
The purpose of this study is to learn if a weight loss program especially designed to address food insecurity is more effective compared to a standard weight loss program. Read more about this study
- Who is it for?
- Ages 21 months to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Standard Weight Management Program and Sensible Weigh Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 months to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Documented low income
- Body Mass Index (BMI) >25.0 kg/m2
- Must speak and understand English
- Able to attend intervention sessions and have access to telephone
Who cannot join
- Report serious medical risk such as insulin-dependent diabetes, cancer, recent cardiac event
- Currently or planning to become pregnant during the intervention
- Have no control over food purchases or choices
- Report participation in a weight reduction program involving diet or PA within past 6 months
- Report symptomology of an eating disorder
- Report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, Atkins, macrobiotic, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to learn if a weight loss program especially designed to address food insecurity is more effective compared to a standard weight loss program.
Read the detailed description
Low income women are at greater risk of both obesity and food insecurity (not having consistent access to nutritious and adequate amounts of food). Most weight loss programs targeted at low income women do not focus on gaining skills and knowledge to reduce food insecurity.
Eligible participants will be randomized into one of two groups. The two groups will follow different weight management programs. One group will follow a standard weight management program. The other group with follow the investigations program, the $ensible Weigh Program. Participation in the study will last about 9 months.
- Conditions
- Weight Loss
- Being tested
- Standard Weight Management Program, Sensible Weigh Program
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Weight Management ProgramOther
Standard Diet program based on diet and exercise.
Sensible Weigh ProgramOther
Weight loss program designed for low income women.
| Study group | Role | What they receive |
|---|---|---|
| Standard Weight Management Program | Active comparator | Participants will be given information on diet and exercise. Participants will attend meetings to discuss barriers to exercise and nutrition and ways to solve these problems. Participants will be given healthy snack ideas and planning tools. Receives: Other: Standard Weight Management Program |
| $ensible Weigh Program | Experimental | Participants will be given information on diet and exercise with an emphasis on food security. Participants will be provided with additional information on community resources such as those for food, transportation, and safe places to exercise. A weekly cooking demonstration will be provided using inexpensive ingredients and common food pantry items. Receives: Other: Sensible Weigh Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing weight management program
Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.
Measured: 9 Months
Secondary outcomes (6)
Change in weight
Change in weight during the weight loss phase
Measured: Change from Baseline to Month 3
Change in weight
Change in weight during the weight management phase
Measured: Change from Month 3 to Month 9
Change in diet quality
Change during the weight loss phase. Change will be measured based on questions answered about participant's diet quality. Changes measured based on lower percentage of calories from fat and increased consumption of fruits, vegetables and whole grains.
Measured: Change from Baseline to Month 3
Change in diet quality
Change during the weight management phase. Change will be measured based on questions answered about participant's diet quality. Changes measured based on lower percentage of calories from fat and increased consumption of fruits, vegetables and whole grains.
Measured: Change from Month 3 to Month 9
Change in food security status
Change during the weight loss phase. Change will be measured based upon responses to the US Household Food Security Questionnaire
Measured: Change from Baseline to Month 3
Change in food security status
Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire
Measured: Change from Month 3 to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeannine Goetz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeannine Goetz, PhD, University of Kansas Medical Center
- Investigators
- Jeannine Goetz, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251587
- Sponsor's protocol ID
- STUDY00001503
- Status last verified
- Feb 2016
- First submitted
- 25 Sep 2014
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The $Ensible Weight Program: An Intervention Tailored for Low Income Women
- ClinicalTrials.gov ID
- NCT02251587
- Acronym / sponsor ID
- STUDY00001503
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jeannine Goetz, PhDUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if a weight loss program especially designed to address food insecurity is more effective compared to a standard weight loss program.
Detailed description
Low income women are at greater risk of both obesity and food insecurity (not having consistent access to nutritious and adequate amounts of food). Most weight loss programs targeted at low income women do not focus on gaining skills and knowledge to reduce food insecurity.
Eligible participants will be randomized into one of two groups. The two groups will follow different weight management programs. One group will follow a standard weight management program. The other group with follow the investigations program, the $ensible Weigh Program. Participation in the study will last about 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Weight Management Program | Active comparator | Other: Standard Weight Management ProgramParticipants will be given information on diet and exercise. Participants will attend meetings to discuss barriers to exercise and nutrition and ways to solve these problems. Participants will be given healthy snack ideas and planning tools. |
| $ensible Weigh Program | Experimental | Other: Sensible Weigh ProgramParticipants will be given information on diet and exercise with an emphasis on food security. Participants will be provided with additional information on community resources such as those for food, transportation, and safe places to exercise. A weekly cooking demonstration will be provided using inexpensive ingredients and common food pantry items. |
Who may qualify
- Ages
- 21 months to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Documented low income
- Body Mass Index (BMI) >25.0 kg/m2
- Must speak and understand English
- Able to attend intervention sessions and have access to telephone
Key exclusion criteria (6 listed)
- Report serious medical risk such as insulin-dependent diabetes, cancer, recent cardiac event
- Currently or planning to become pregnant during the intervention
- Have no control over food purchases or choices
- Report participation in a weight reduction program involving diet or PA within past 6 months
- Report symptomology of an eating disorder
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 |
|---|---|---|
| Standard Weight Management ProgramStandard Diet program based on diet and exercise. | Other | Standard Weight Management Program |
| Sensible Weigh ProgramWeight loss program designed for low income women. | Other | $ensible Weigh Program |
Primary outcome
Feasibility of implementing weight management program
Time frame: 9 Months
Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.
6 secondary outcomes
Change in weight
Time frame: Change from Baseline to Month 3
Change in weight
Time frame: Change from Month 3 to Month 9
Change in diet quality
Time frame: Change from Baseline to Month 3
Change in diet quality
Time frame: Change from Month 3 to Month 9
Change in food security status
Time frame: Change from Baseline to Month 3
Change in food security status
Time frame: Change from Month 3 to Month 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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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.
Jeannine Goetz, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Weight Management Program and Sensible Weigh Program in people with Weight Loss, run by Jeannine Goetz, PhD 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 4 inclusion and 6 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 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing weight management program (time frame: 9 Months). 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 3 Feb 2016; AzTrials last refreshed its copy on 29 Oct 2026.