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Construct validity of the 12-item Short Form Health Survey (SF-12) version 2 and the impact of lifestyle modifications on the health-related quality of life among Indian adults with prediabetes: results from the D-CLIP trial

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Abstract

Purpose

This study aimed to validate the factor structure of the 12-item Short-Form (SF-12) health-related quality of life (HRQOL) survey for Indian adults and assess the impact of lifestyle modification on the SF-12 of Indian adults with prediabetes.

Methods

To validate the context-specific construct of the SF-12, two-factor confirmatory factor analysis (CFA) was performed using data from 1285 adults residing in Chennai, India, who screened for the Diabetes Community Lifestyle Improvement Program (D-CLIP). D-CLIP was a randomized controlled trial of 578 participants with prediabetes (283 treatment, 293 control), focusing on the effect of lifestyle modifications on the prevention of diabetes. Physical and mental component scores (PCS and MCS) were computed by using CFA standardized factor loadings. Multiple linear regression was subsequently conducted to estimate the effect of lifestyle modification on post-study changes of PCS and MCS among D-CLIP participants.

Results

Cronbach’s alpha and CFA fit indices demonstrated acceptable reliability and model fit of the SF-12 for Indian adults. The intervention group showed greater mean change in PCS after study participation compared to the controls (1.63 ± 0.82, p = 0.046); no significant difference was observed for MCS between two groups (1.00 ± 0.85, p = 0.242).

Conclusion

The study confirmed that the SF-12 is suitable for assessing the physical and mental health dimensions of HRQOL for Indian adults. Our findings suggest that the benefits of diabetes prevention lifestyle modification strategies may primarily enhance the physical well-being of adults with prediabetes. Further studies validating the SF-12 in a broader Asian Indian population are needed.

Trial registration

Clinicaltrials.gov, NCT01283308.

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Data availability

N/A, the study data can only be accessed by investigators registered in the IRB and their groups.

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Acknowledgements

This project is supported by a BRiDGES grant from the International Diabetes Federation (LT07-115). BRiDGES, an International Diabetes Federation project, is supported by an educational grant from Lilly Diabetes. Additional support was provided by the Global Health Institute at Emory University. Additional support was provided through P30DK111024 from NIH/NIDDK. We also express our appreciation to Ms. Sharfaa Junaid who supported the preliminary analysis of this project.

Funding

This project is supported by a BRiDGES grant from the International Diabetes Federation (LT07-115). BRiDGES, an International Diabetes Federation project, is supported by an educational grant from Lilly Diabetes. Additional support was provided by the Global Health Institute at Emory University. Additional support was provided through P30DK111024 from NIH/NIDDK.

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Authors and Affiliations

  1. Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, USA

    Euisun Pyo, Mary Beth Weber & Lisa R. Staimez

  2. Madras Diabetes Research Foundation, Chennai, India

    Jayalakshmi Sivaram

  3. Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA

    Mary Beth Weber & Lisa R. Staimez

  4. Department of Diabetology, Madras Diabetes Research Foundation and Dr. Mohan’s Diabetes Specialities Centre, Chennai, India

    Viswanathan Mohan & Ranjit Mohan Anjana

  5. Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, GA, USA

    Regine Haardörfer

  6. Department of Preventive and Digital Health Research, Madras Diabetes Research Foundation, Chennai, India

    Harish Ranjani

  7. Emory Global Diabetes Research Center, Woodruff Health Sciences Center, Emory University, Atlanta, GA, 30322, USA

    Mary Beth Weber & Lisa R. Staimez

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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Harish Ranjani, Jayalakshmi Sivaram, Mary Beth Weber, and Euisun Pyo. The first draft of the manuscript was written by Euisun Pyo, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Euisun Pyo.

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The authors have no relevant financial or non-financial interests to disclose.

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Emory University Institutional Review Board (IRB-00016503) and the Madras Diabetes Research Foundation Ethics Committee approved the study.

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All participants gave written informed consent before screening and randomization.

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All participants gave written informed consent for the publication of their data for research purposes.

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Pyo, E., Weber, M.B., Sivaram, J. et al. Construct validity of the 12-item Short Form Health Survey (SF-12) version 2 and the impact of lifestyle modifications on the health-related quality of life among Indian adults with prediabetes: results from the D-CLIP trial. Qual Life Res (2024). https://doi.org/10.1007/s11136-024-03648-6

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