ObesityTOPS at DOCNCT03202420
Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
A study testing TOPS in people with Obesity, run by Duke University at 1 site in United States.
Trial summary
The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- TOPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2017to 5 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be patients of the DOC.
- BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).
Who cannot join
- Mental illness that would cause disruptions to group meetings
- Cognitive impairment that would preclude participants from understanding the program
- Type 2 diabetics on insulin or sulfonylureas without provider approval
- untreated hyper- or hypothyroidism
- current cancer diagnosis
- history of cancer (other than skin cancer)
Show all 14Show fewer
- gastrointestinal disorders affecting food intake
- use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
- women currently pregnant or lactating, planning to become pregnant, or less than 6 months post-partum
- weight loss of > 5% in past 6 months
- major psychiatric disorder
- current moderate to severe symptoms of depression
- eating disorders
- current alcohol or substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke General Internal Medicine
Durham, North Carolina, 27701
About this study
Official title: Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics.
To achieve these goals, the investigators will pursue the following Specific Aims:
Read more
Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups.
Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants.
Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks.
Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.
- Conditions
- Obesity
- Being tested
- TOPS
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOPSOther
Take Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management.
| Study group | Role | What they receive |
|---|---|---|
| TOPS | Experimental | Participants will attend weekly TOPS meetings with standard weekly weigh ins Receives: Other: TOPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.
Measured: Baseline, 12, 24, and 52 weeks
Secondary outcomes (2)
Program Attendance
Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).
Measured: 52 Weeks
Retention as measured by attendance sheets
Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks.
Measured: 12, 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start22 Dec 2017
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
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.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nia S Mitchell, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202420
- Sponsor's protocol ID
- Pro00080518
- Acronym
- TOPS at DOC
- Status last verified
- Feb 2020
- First submitted
- 27 Jun 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
- ClinicalTrials.gov ID
- NCT03202420
- Acronym / sponsor ID
- TOPS at DOC / Pro00080518
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 28 Jun 2017 (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 purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics.
To achieve these goals, the investigators will pursue the following Specific Aims:
Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups.
Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants.
Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks.
Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOPS | Experimental | Other: TOPSParticipants will attend weekly TOPS meetings with standard weekly weigh ins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be patients of the DOC.
- BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).
Key exclusion criteria (14 listed)
- Mental illness that would cause disruptions to group meetings
- Cognitive impairment that would preclude participants from understanding the program
- Type 2 diabetics on insulin or sulfonylureas without provider approval
- untreated hyper- or hypothyroidism
- current cancer diagnosis
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 |
|---|---|---|
| TOPSTake Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management. | Other | TOPS |
Primary outcome
Change in Weight
Time frame: Baseline, 12, 24, and 52 weeks
Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.
2 secondary outcomes
Program Attendance
Time frame: 52 Weeks
Retention as measured by attendance sheets
Time frame: 12, 24 and 52 weeks
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 17 Feb 2020.
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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.
Nia S Mitchell, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOPS in people with Obesity, run by Duke 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 2 inclusion and 14 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 17 Feb 2020. 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?
Change in Weight (time frame: Baseline, 12, 24, and 52 weeks). 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 17 Feb 2020.