An interventional study of Lifestyle Program and Usual Care in Weight Loss, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-13.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment
This study will examine whether an adapted version of ]he Diabetes Prevention Program (DPP) can be effective when delivered by community health workers (CHWs) in a poor urban community in South Africa. We will randomize existing groups that are part of an non-governmental organization's (NGO) chronic disease management program (anticipated cluster N = 54; anticipated individual N=540), to receive either the program or usual care (wait-list). The primary outcome analysis will compare percentage of baseline weight loss at Y1 between the program and usual care; however, after Y1 usual care participants will also receive the program and both groups will be followed for another year.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
This study's enrollment of 494 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
Behavioral: Lifestyle Program · Other: Usual Care
Participants receive usual care and after 1 year receive the Lifestyle Program intervention
Other: Usual Care
Participants will receive group weight loss sessions addressing healthy eating, exercise, and weight loss principles adapted from the Diabetes Prevention Program delivered by Community Health Workers.
Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.
Weight loss
percentage weight loss (weight measured in kilograms)
Time frame: 1 year
Blood pressure
systolic blood pressure (mmHG), diastolic blood pressure (mmHG)
Time frame: 1 year
HbA1c
percent
Time frame: 1 year
LDL cholesterol
mg/dl
Time frame: 1 year
Triglycerides
mg/dl
Time frame: 1 year
Plan to share: No
Ran from Feb 2018 to primary completion in Nov 2019, 20 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 20 months is below 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 May 2022. You cannot join it, but the record below documents what was studied.
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