An interventional study of Video Conference Meetings and In-person Meetings in Obesity, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
Among 32 studies in Obesity by University of Kansas Medical Center — 9 open to participants now, 9 under way, none of them phase 3. Obesity · University of Kansas Medical Center.
Among the 32 studies in Obesity by University of Kansas Medical Center, this one is the 9th largest by enrollment of the 29 interventional ones that give a count, is one of 4 that started in 2018, is one of 28 with no phase, and was the 12th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →9 of the 32 studies in Obesity by University of Kansas Medical Center are open now, in 1 country. Recruiting first, the newest first:
University of Kansas Medical Center · Sites in United States
University of Kansas Medical Center · Sites in United States
University of Kansas Medical Center · Sites in United States
University of Kansas Medical Center · Sites in United States
University of Kansas Medical Center · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2018.
This study's enrollment of 120 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 60 across the 29 interventional studies, 60 across the 3 observational. Of the 22 that completed or were terminated, 8 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
2 of the studies in Obesity by University of Kansas Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06640179University of Kansas Medical CenterFeasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL) | 2027-02-01 |
| NCT05985486University of Kansas Medical CenterBrain Outcomes With Lifestyle Change in Down Syndrome | 2027-09-30 |
Among the 32 studies in Obesity by University of Kansas Medical Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
Behavioral: In-person Meetings · Behavioral: Enhanced Stop Light Diet · Behavioral: Physical Activity
Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
Behavioral: Video Conference Meetings · Behavioral: Enhanced Stop Light Diet · Behavioral: Physical Activity
Individual video conferencing with a health educator using an iPad.
Individual face-to-face (FTF) meetings with a health educator.
Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).
Also known as: eSLD
Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week.
Change in Weight (kg)
Change in weight (kg) from baseline to 6 months
Time frame: Change from Baseline to Month 6
Change in Weight (kg)
Change in weight across the 24 month study
Time frame: Change from Baseline to Month 24
| Milestone | Face to Face | Remote Delivery |
|---|---|---|
| Started | 60 | 60 |
| 6 months | 53 | 57 |
| 18 months | 39 | 48 |
| Completed | 33 | 46 |
| Not completed | 27 | 14 |
Change in weight (kg) from baseline to 6 months
| kg | Face to Face | Remote Delivery |
|---|---|---|
| Change in Weight (kg) | -2.1 ± 6.7 | -4.9 ± 7.8 |
Change in weight across the 24 month study
| kg | Face to Face | Remote Delivery |
|---|---|---|
| Change in Weight (kg) | -2.3 ± 10.1 | -4.5 ± 10.3 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Face to Face | 1/60 (1.7%) | 1/60 (1.7%) | 3/60 (5%) |
| Remote Delivery | 0/60 (0%) | 1/60 (1.7%) | 3/60 (5%) |
| Event | Face to Face | Remote Delivery |
|---|---|---|
| DeathRespiratory, thoracic and mediastinal disorders | 1/60 | 0/60 |
| Cardiac ArrestCardiac disorders | 0/60 | 1/60 |
| Event | Face to Face | Remote Delivery |
|---|---|---|
| Broken BoneMusculoskeletal and connective tissue disorders | 3/60 | 0/60 |
| Muscle StrainMusculoskeletal and connective tissue disorders | 0/60 | 3/60 |
| Age, Continuous(years) | Face to Face | Remote Delivery | Total |
|---|---|---|---|
| Mean | 33.5 ± 11.7 | 30.6 ± 8.0 | 32.1 ± 10.1 |
| Sex: Female, Male(Participants) | Face to Face | Remote Delivery | Total |
|---|---|---|---|
| Female | 35 | 28 | 63 |
| Male | 25 | 32 | 57 |
| Ethnicity (NIH/OMB)(Participants) | Face to Face | Remote Delivery | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 4 | 9 |
| Not Hispanic or Latino | 55 | 56 | 111 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Face to Face | Remote Delivery | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 5 | 12 |
| White | 49 | 54 | 103 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight (kg)(kg) | Face to Face | Remote Delivery | Total |
|---|---|---|---|
| Mean | 101.5 ± 27.5 | 94.4 ± 25.8 | 97.9 ± 26.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Mar 2021, 36 months.
Results were first posted in Mar 2023, 1 year 11 months after primary completion.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 36 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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