An interventional study of Presurgical Counseling in Weight Loss, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
Among 995 studies in Weight Loss with a site in United States — 114 open to participants now, 169 under way, 6 of them phase 3. Weight Loss · United States.
Among the 995 studies in Weight Loss with a site in United States, this one is the 876th largest by enrollment of the 912 interventional ones that give a count, is one of 44 that started in 2019, is one of 714 with no phase, and was the 551st registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →114 of the 995 studies in Weight Loss with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Icahn School of Medicine at Mount Sinai · Sites in United States
Morehouse School of Medicine · Sites in United States
Duke University · Sites in United States
Viking Therapeutics, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.
This study: 19 Years to 55 Years · all sexes · healthy volunteers too.
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995 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 106 · Phase 3 38 · Phase 4 33
First in 1996; this study’s year is marked. 44 started in 2019.
This study's enrollment of 5 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 72 across the 912 interventional studies, 99 across the 76 observational. Of the 769 that completed or were terminated, 230 (30%) have results posted.
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116 of 995 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 5 studies filed under Weight Loss — fewer than ten, so there is no comparison to draw.
57 of the studies in Weight Loss with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07298915Phase 3University of VirginiaThe Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) | 2026-12 |
| NCT07223242Phase 3University of Texas Southwestern Medical CenterTailored Exercise Training Study Among Adults With HFpEF | 2026-12-30 |
| NCT07104383Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) | 2027-07-01 |
| NCT07104500Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Phase 3 | 2027-07-01 |
| NCT07560579Million Marker Wellness, Inc.Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity | 2026-11 |
Among the 995 studies in Weight Loss with a site in United States, from their registry updates:
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Childhood obesity has been a growing problem with more than 30% of children between 6 and 19 years old being considered overweight or obese. Obese children are at increased risk of developing diabetes, heart disease, metabolic syndrome, and are susceptible to the sociological effects of being overweight. Obesity is a multifactorial disease, is often familial and multi-generational, and studies have shown that parental obesity can increase the risk of a child becoming obese. Currently, one of the most successful treatment options for obesity is bariatric surgery. The Nebraska Medicine Bariatric Center offers patients counseling in improved dietary management, methods to increase physical activity, and psychological support. As part of the programs standard-of-care, each bariatric surgical patient receives consultation with a dietician, psychologist, and an exercise physiologist. We propose that mothers who are enrolled in the surgical weight loss program bring their children to attend the presurgical specialist consultation. Subjects enrolled in the study will have their height, weight, and physical activity assessed at preoperative and postoperative study visits. Study subjects will also complete questionnaires of their self-reported physical activity and eating habits at these study visits. The goal of this pilot study is to examine whether this behavioral intervention will have an impact on the overall health and weight of children whose mothers have received bariatric surgery.
This is a prospective intervention study of female bariatric surgical patients and their children. The dyads, consisting of one female bariatric patients and one child living in the home, will be enrolled in the study. Half of the children will attend the dietary, physical activity, and psychological counseling with the mother prior to her surgery, and the other half of the children will not receive the behavioral intervention. Outcomes from each mother-child dyad will be measured at baseline, and 3 and 6 months postoperatively (Visit BL-2, Visit PO-3, and Visit PO-6). The primary outcome measured from each dyad will be BMI, and secondary outcomes will be physical activity and energy expenditure (as measured by an accelerometer at each research study visit) and self-reported diet and physical activity (as measured by questionnaires completed at each research study visit).
Each bariatric surgical patient will receive a consultation with a dietician, psychologist, and an exercise physiologist as standard-of-care. These specialist consultations usually take place sequentially in the same day. The intervention aspect of this study is to include the child with the mother for these specialist consultations. The dietician will educate the patient as to dietary modifications that will be needed both before and after bariatric surgery. The psychologist will review any existing psychological conditions with the patient and discuss behavioral and pharmaceutical management of these conditions in conjunction with the bariatric surgery. The exercise physiologist will discuss physical restrictions to exercise and modifications to an exercise regimen that can be properly performed by the patient.
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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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children will attend presurgical visits with their mother
Behavioral: Presurgical Counseling
Children will not attend presurgical visits with their mother
Children will attend the presurgical counseling visits with their mother
Also known as: No Intervention
Maternal weight loss
Weight loss
Time frame: presurgical, 3 mos, 6 mos
Child weight loss
weight loss
Time frame: presurgical, 3 mos, 6 mos
Maternal Activity level
activity level
Time frame: presurgical, 3 mos, 6 mos
Child Activity Level
activity level
Time frame: presurgical, 3 mos, 6 mos
Maternal diet
Self-reported diet
Time frame: presurgical, 3 mos, 6 mos
Child diet
self-reported diet
Time frame: presurgical, 3 mos, 6 mos
Plan to share: No — Individual patient data will not be made available to other researchers
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Sep 2022, 44 months.
Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 44 months is above that.
Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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