Effectiveness and implementation of a lifestyle modification intervention for women with isolated impaired fasting glucose: Study protocol for a hybrid type 2 study in Kerala, India
Bibliographic record
Abstract
<ns4:p> <ns4:bold>Background:</ns4:bold> Isolated impaired fasting glucose (i-IFG) constitutes a major group in the prediabetic spectrum among Indians, and thus it is imperative to identify effective diabetes prevention strategies. This study aims to evaluate the effects of an intensive community-based lifestyle modification program on regression to normoglycemia among women with i-IFG, compared to a control group at 24 months. The study also aims to evaluate the implementation of the intervention, via both process and implementation outcomes. </ns4:p> <ns4:p> <ns4:bold>Methods:</ns4:bold> We will use a hybrid design (Effectiveness-implementation hybrid type 2 trial) to test the effectiveness and implementation of the lifestyle modification intervention. Effectiveness is evaluated using a randomized controlled trial among 950 overweight or obese women, aged 30 to 60 years, with i-IFG on an oral glucose tolerance test in the Indian state of Kerala. The intervention involves an intensive lifestyle modification program through group and individually mentored sessions using behavioural determinants and behavioural change techniques. The intervention group will receive the intervention for a period of 12 months and the control group will receive general health advice through a health education booklet. Data on behavioural, clinical, and biochemical measures will be collected using standard methods at 12 and 24 months. The primary outcome will be regression to normoglycemia at 24 months, as defined by the American Diabetes Association criteria. </ns4:p> <ns4:p> <ns4:bold>Discussion</ns4:bold> : This study will provide the first evidence on the effects of lifestyle interventions on regression to normoglycemia in people with i-IFG among Indians. </ns4:p> <ns4:p> <ns4:bold>CTRI registration:</ns4:bold> CTRI/2021/07/035289 (30/07/2021) </ns4:p>
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".