Effects of Weight Loss Management on Cognitive Function in Elderly Women With Obesity (NCT05841173) | Clinical Trial Compass
UnknownNot Applicable
Effects of Weight Loss Management on Cognitive Function in Elderly Women With Obesity
Russia200 participantsStarted 2022-01-09
Plain-language summary
According to studies, the risk of cerebrovascular disease and cognitive decline are associated with age-related changes. In addition, there is data suggesting a relationship between the progression of this pathology and the presence of obesity and associated metabolic disorders. According to to some research, weight loss associated with cognitive function decline. In this regard, the development of effective, applicable in real clinical practice methods of non-drug treatment and prevention of cerebrovascular disorders and age-related cognitive decline in people with obesity and metabolic disorders, who are at high risk, seems to be extremely relevant.
The main goal of the study is to compare the effectiveness of various weight loss approaches and to study their effects on the cognitive functions of elderly obesity women.
Who can participate
Age range
60 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female;
. Age 60 and over;
. BMI 30.0 kg/m2 or more.
Exclusion criteria
. Male;
. age under 60;
. BMI \<30.0 kg/m2;
. patients unable or unwilling to comply with the requirements of the protocol, including the signing of informed consent (inability to give such consent due to mental deficiency or language barrier), as well as non-compliance with the schedule of visits, persons unable to independently make a decision and sign an informed consent;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline body weight at 12 weeks
Timeframe: Baseline (visit 1) and after 12 weeks (visit 2)
2
Change from baseline Montreal Cognitive Assessment (MoCa) test scores at 12 weeks
Timeframe: Baseline (visit 1) and after 12 weeks (visit 2)
3
Change from baseline Trail Making Test (TMT) a&b test scores at 12 weeks
Timeframe: Baseline (visit 1) and after 12 weeks (visit 2)
4
Change from baseline Word recall test scores at 12 weeks
Timeframe: Baseline (visit 1) and after 12 weeks (visit 2)
5
Change from baseline Mean response time in the test "Schulte tables" at 12 weeks
Timeframe: Baseline (visit 1) and after 12 weeks (visit 2)
6
Change from baseline The Stroop Color and Word Test results at 12 weeks
Timeframe: Baseline (visit 1) and after 12 weeks (visit 2)
7
Change from baseline Verbal fluency test results at 12 weeks
Trial details
NCT IDNCT05841173
SponsorFederal State Budgetary Scientific Institution