Protocol diabetes prevention program

Similarly, change in diabetes knowledge and health literacy score will be analysed by linear mixed models. Per-protocol analysis will be performed as sensitivity analysis including participants of intervention clusters who have attended all four intervention sessions.

In all analyses, standard errors will be estimated by a clustered sandwich estimator. English transcripts of the interviews will be read several times to become familiar with the discussions and obtain manifesting meanings. There will be at least two team members who will review the data.

The meaning units and codes will be condensed to create subcategories and categories depending on their cohering findings. Categories capture the fullness of the experiences and actions studied. This study involves human participants and wasapproved by an Ethics Committee s or Institutional Board s.

Also, written permission from Dhulikhel Municipality and LMC have been obtained to conduct the study. A key output of this project will be to facilitate the implementation of this DiPEP package in other communities of Nepal if this intervention programme is effective in preventing diabetes. General public were involved during the development stage of the diabetes prevention brochure and were asked to give us the feedback in order to improvise and finalise it.

The public was not directly involved in developing research questions, study design, intervention designs and outcome measures. The results of this study will be disseminated to the associated organisations, local committees, etc. Diabetes is a serious global health concern and imposes an economic burden on the healthcare system particularly in resource-limited countries like Nepal.

Evidence suggests that individuals originating from Asian countries develop type 2 diabetes at a higher rate than Caucasians counterparts. Therefore, the selection of an appropriate target population and cost-effective diabetes prevention lifestyle intervention strategies are much needed. Moreover, as this trial is conducted in a resource-constrained country like Nepal, the results of this study might influence activities in other LMIC.

Nepal has a federal government, and each municipality has its independence to plan and conduct programmes required for its population.

Hence, these kinds of community-based prevention programmes would be resourceful in preventing diabetes. The main strength of this study is that it is a randomised trial making it possible to evaluate the effectiveness of the lifestyle intervention programme DiPEP to prevent diabetes.

The use of cluster randomisation allows identification of effects when randomisation at the individual level is not suitable. Second, as all cluster participants will be offered the same intervention, this may ease the recruitment process, simplify administrative tasks and enhance compliance due to interaction among cluster participants in the intervention arm.

Third, cluster randomisation may help to prevent contamination due to sharing of information between intervention and control participants. There are some limitations in this study. First, in general, a cluster RCT design may require a larger sample size than a trial with randomisation at the individual level because of intracluster correlation.

Second, there might be a possibility of potential spillover among participants in intervention and control groups due to short geographical distances between clusters and potential contact with participants in other clusters. However, to reduce this risk, we will provide intensive education sessions with follow-up to the specific group participants of the intervention arm.

Third, participation of only interested candidates in the screening camps might also lead to selection bias. Fourth, the variability in HbA1c result with POCT and lab test should be considered if the test results from POCT method in this study are to be compared with results from lab test because of the use of different methods and agents in these two methods and also because of discrepancies between capillary, venous and arterial blood sample. Authors would like to remember the contribution of the Late Dr.

Kedar Manandhar, who guided in the initial phase of project design. This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author s and has not been edited for content. PS and ArS sampled the study participants. ArS and ES contributed to the technical design and provided biostatistical and epidemiological support.

PS and AbSe drafted the manuscript. All authors critically revised the manuscript for important intellectual content and approved the final version. Funding The grant was obtained by BEK.

Provenance and peer review Not commissioned; externally peer reviewed. Supplemental material This content has been supplied by the author s. Any opinions or recommendations discussed are solely those of the author s and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. You will be able to get a quick price and instant permission to reuse the content in many different ways.

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Forgot your log in details? Register a new account? Forgot your user name or password? Search for this keyword. Advanced search. Log in via Institution. Email alerts. Article Text. Article menu. Public health. Abstract Introduction Evidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. Statistics from Altmetric. Introduction The prevalence of diabetes is increasing globally 1 and is expected to increase from million to million by the year Supplemental material [bmjopensupp Study population The inclusion and exclusion criteria of the study population are presented in table 1.

View this table: View inline View popup. Table 1 Inclusion and exclusion criteria of the study. Sample size It has been estimated that a total of pre-diabetes individuals in each arm; 32 per cluster are needed to detect a minimum detectable difference in HbA1c of 0. Figure 1 Consort diagram. Randomisation Out of four clusters in Dhulikhel Municipality, two will be randomised to the intervention arm and other two to the control arm.

Health Care Professionals. Employers and Insurers. Links with this icon indicate that you are leaving the CDC website. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Researchers met with participants individually at least 16 times in the first 24 weeks, and then every 2 months with at least 1 phone call between visits.

Metformin Group — Group participants took mg of metformin twice a day and were provided standard advice about diet and physical activity. Placebo Group — Group participants took a placebo twice a day instead of metformin and were provided standard advice about diet and physical activity. DPPOS Results Year Findings At the year follow-up participants who took part in the DPP Lifestyle Change Program continued to have a delay in the development of diabetes by 34 percent—and developed diabetes about 4 years later—compared with participants who took a placebo.

Participants from the DPP Lifestyle Change Program ages 60 and older had a delay in the development of diabetes by 49 percent. However, the participants from the DPP Lifestyle Change Program achieved these results with fewer blood pressure and cholesterol-lowering medications. However, women from the DPP Lifestyle Change Program developed fewer small blood vessel problems than participants who continued to take metformin or took a placebo.

Participants who did not develop diabetes had a 28 percent lower rate of small blood vessel problems compared with participants who developed diabetes. There were some changes to the treatments each group received: Lifestyle Change Group —Group participants received quarterly group lifestyle change classes throughout the study and two group classes yearly to reinforce self-management behaviors for weight loss. Metformin Group — Group participants received quarterly group lifestyle change classes throughout the study.

Extensive centralized feedback, training, and support were provided to all DPP centers. Jackson Foundation provided support services under subcontract with the Coordinating Center. We thank the thousands of volunteers in this program for their devotion to the goal of diabetes prevention. National Center for Biotechnology Information , U.

Diabetes Care. Author manuscript; available in PMC Nov Author information Copyright and License information Disclaimer. E-mail: ude. Copyright notice. The publisher's final edited version of this article is available at Diabetes Care.

See other articles in PMC that cite the published article. Table 1 Key aspects of the DPP lifestyle protocol. Open in a separate window. Goal-based behavioral intervention The DPP lifestyle intervention was designed to be administered consistently across the 27 centers and 1, participants in this arm of the trial and to allow maximum flexibility, given the heterogeneity of the participants.

Frequent contact and ongoing intervention The DPP was designed as a study of the efficacy of lifestyle changes in preventing or delaying diabetes.

Core curriculum The lifestyle intervention commenced with a session core curriculum that was to be completed within the first 24 weeks after randomization. Table 2 DPP session core curriculum.

Session 1. Introduce self-monitoring of food intake. Session 2. Assign a fat gram goal based on starting weight. Session 3. Teach three ways to eat less fat: eat high-fat foods less often, eat smaller portions, and substitute lower fat foods and cooking methods. Session 4. Recommend specific low-fat, low-calorie substitutes at each level of the Food Pyramid. Session 5. Begin self-monitoring of physical activity as well as food intake. Review personal activity history and likes and dislikes about physical activity.

Encourage attendance at group supervised activity sessions. Session 6. Teach the basic principles for exercising safely, what to do in the event of injury, and knowing when to stop.

Session 7. For those individuals who have made little progress with weight loss, assign self-monitoring of calories as well as fat grams or provide a structured meal plan at reduced calorie levels. Session 8. Session 9. Apply the problem-solving model to eating and exercise problems.

Session Teach participants to recognize personal triggers for slips, their reactions to those slips, and what it takes to get back on track. Teach participants to measure their heart rate and perceived level of exertion as a way of determining the appropriate levels of activity.

Discuss ways to cope with boredom by adding variety to the physical activity plan. Review specific strategies for coping with social events such as parties, vacations, and holidays. Introduce other strategies for staying motivated including posting signs of progress, setting new goals, creating friendly competition, and seeking social support from DPP staff and others. Self-monitoring of weight Participants were weighed privately at the start of every individual session and were encouraged to weigh themselves at home daily or a minimum of once per week.

Dietary modification The initial focus of the dietary intervention was on reducing total fat rather than calories. Supervised activity sessions The protocol required that each clinical center offer supervised physical activity sessions at least two times per week throughout the trial. Extensive network of centralized training, feedback, and support In addition to local team support, a key feature of the DPP lifestyle intervention was an extensive centralized network of training, feedback, and support of the intervention staff.

Training All lifestyle coaches were required to attend annual, 2-day national training sessions conducted by the Lifestyle Resource Core. References 1. The Diabetes Prevention Program: design and methods for a clinical trial in the prevention of type 2 diabetes.

Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. Eriksson KF, Lindgarde F. Prevention of type 2 non-insulin-dependent diabetes mellitus by diet and physical exercise. Can life-styles of subjects with impaired glucose tolerance be changed?