Dataset Information

A pragmatic lifestyle modification programme reduces the incidence of predictors of cardio-metabolic disease and dysglycaemia in a young healthy urban South Asian population: a randomised controlled trial.

ABSTRACT:

Background

There is an increasing incidence of type 2 diabetes mellitus (T2DM) in young urban South-Asians. We tested the effect of a pragmatic trimonthly lifestyle modification (LSM) programme (P-LSM) versus a less-intensive 12-monthly control LSM (C-LSM) intervention on a primary composite endpoint of predictors of cardio-metabolic disease (new onset T2DM, hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia (IFG) and markers of cardio-renal disease) in participants aged 5-40 years with risk factors for T2DM.

Methods

This was a randomised controlled trial performed at the National Diabetes Centre, Sri-Lanka. We individually randomised 4672 participants at risk of T2DM, of whom 3539 (mean age 22.5 (range 6-40 years, 48% males) received either trimonthly (P-LSM n?=?1726) or 12-monthly (C-LSM n?=?1813) peer educator advice aimed at reducing weight, improving diet, reducing psychological stress and increasing physical activity.

Results

During a median follow-up of 3 years, the cumulative incidence of the primary endpoint was n?=?479 in P-LSM (74 per 1000 person years) vs. 561 in C-LSM (96 per 1000 person years), with an incident rate ratio (IRR) of 0.89 (95% CI 0.83-0.96, P?=?0.02). In post hoc analyses, new onset dysglycaemia (T2DM, IFG and IGT), was the major contributor to the composite and was significantly reduced by P-LSM (IRR 0.9, 95% CI 0.83-0.97, P?=?0.01). A significant impact of P-LSM on the incidence of the composite endpoint was noted in 1725 participants (P-LSM n?=?850, C-LSM n?=?875) aged below 18; P-LSM n?=?140 (48 per 1000 person years) versus C-LSM n?=?174 (55.4 per 1000 person years), with an IRR of 0.83 (95% CI 0.73-0.94, P?=?0.004).

Conclusions

In a young at-risk South-Asian population, a pragmatic LSM programme significantly reduces the incidence of predictors of cardio-metabolic disease. Our results highlight the importance of early intervention in young at-risk subjects.

Trial registration

World Health Organization international clinical trial registry platform ( SLCTR/2008/003 ). Registration Date: March 28, 2008. Retrospectively registered.

SUBMITTER: Wijesuriya M

PROVIDER: S-EPMC5576225 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A pragmatic lifestyle modification programme reduces the incidence of predictors of cardio-metabolic disease and dysglycaemia in a young healthy urban South Asian population: a randomised controlled trial.

Wijesuriya Mahen M Fountoulakis Nikolaos N Guess Nicola N Banneheka Sarath S Vasantharajah Laksha L Gulliford Martin M Viberti Giancarlo G Gnudi Luigi L Karalliedde Janaka J

BMC medicine 20170830 1

<h4>Background</h4>There is an increasing incidence of type 2 diabetes mellitus (T2DM) in young urban South-Asians. We tested the effect of a pragmatic trimonthly lifestyle modification (LSM) programme (P-LSM) versus a less-intensive 12-monthly control LSM (C-LSM) intervention on a primary composite endpoint of predictors of cardio-metabolic disease (new onset T2DM, hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia (IFG) and markers of cardio-renal disease) in participan ...[more]

PMID: 28851373

Similar Datasets

Project description:BackgroundWe have previously demonstrated in the DIABRISK-SL trial that a trimonthly pragmatic lifestyle modification (P-LSM), as compared to a 12-monthly LSM advice (C-LSM), significantly reduced the primary composite endpoint of predictors of cardio-metabolic disease (new onset type 2 diabetes (T2DM), hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia and markers of cardio-renal disease) in urban participants aged below 40?years with risk factors for T2DM.Main textWe now report results of post hoc analyses for those aged below 18 (n?=?1725) in three age groups, specifically of 6-10?years (P-LSM n?=?77, C-LSM n?=?59), 10-14?years (P-LSM n?=?534, C-LSM n?=?556) and 14-18?years (P-LSM n?=?239, C-LSM n?=?260). There was no effect of P-LSM on the primary endpoint in participants aged below 10?years. Participants aged 10-14?years in the P-LSM intervention as compared to C-LSM had a lower incidence of the primary combined endpoint (87 vs. 106 cases; incident rate ratio (IRR)?=?0.85, 95% confidence intervals (CI) 0.72-1.01; P?=?0.07), driven mainly by the lower incidence of new onset hypertension (24 vs. 37 cases; IRR?=?0.67, 95% CI 0.49-0.91; P?=?0.012). Participants aged 14-18?years in the P-LSM intervention had a lower incidence of the composite endpoint (36 vs. 54 cases; IRR?=?0.73, 95% CI 0.57-0.94; P?=?0.015) as well as a lower incidence of IGT (12 vs. 21 cases; IRR?=?0.6, 95% CI 0.39-0.92; P?=?0.02), new onset hypertension (6 vs. 15 cases; IRR?=?0.43, 95% CI 0.25-0.76; P?=?0.004), and new onset dysglycaemia (composite of new T2DM, IGT and impaired fasting glycaemia) (30 vs. 46 cases; IRR?=?0.74, 95% CI 0.56-0.97; P?=?0.03) compared to those assigned to the C-LSM intervention. Limitations of the analyses are the post hoc approach and the small number of events in each group. There were no differences in retention between the two groups.ConclusionsOur results suggest that, in young South Asians aged between 10 and 18?years at risk of T2DM, a pragmatic lifestyle modification programme may reduce the incidence of predictors of T2DM and hypertension. There is a need for further studies in younger populations to evaluate the impact and feasibility of interventions to reduce the burden of T2DM and associated cardio-metabolic risk. Please see related article: https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0905-6.

Project description:INTRODUCTION:It has been estimated that a 10%-25% reduction in seven key risk factors could potentially prevent 1.1-3.0?million Alzheimer's disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia. METHODS AND ANALYSIS:A randomised controlled trial (RCT) is being conducted to evaluate three intervention programmes using a pragmatic approach suitable to the clinic: (1) a 12-week online and face-to-face dementia risk-reduction intervention (Body Brain Life-General Practice (BBL-GP)); (2) a 6-week face-to-face group lifestyle modification programme (LMP); and (3) a 12-week email-only programme providing general health information. We aim to recruit 240 participants, aged 18 and over, to undergo a comprehensive cognitive and physical assessment at baseline and follow-ups (postintervention, 18, 36 and 62 weeks). The primary outcome is dementia risk measured with the modified version of the Australian National University-Alzheimer's Disease Risk Index Short Form. Secondary outcomes are cognitive function measured with Trails A and B, and the Digit Symbol Modalities Test; physical activity with moderate-vigorous physical activity and the International Physical Activity Questionnaire; depression with the Centre for Epidemiological Studies Depression; cost evaluation with the 12-item Short Form Health Survey, Framingham Coronary Heart Disease Risk Score and Australian Type 2 Diabetes Risk Assessment Tool; diet quality with the Australian Recommended Food Score; and sleep quality with the Pittsburgh Sleep Quality Index. ETHICS AND DISSEMINATION:This RCT is a novel pragmatic intervention applied in a primary care setting to reduce the dementia risk exposure in adults at high risk. If successful, BBL-GP and LMP will provide a versatile, evidence-based package that can be easily and quickly rolled out to other primary care settings and which can be scaled up at relatively low cost compared with other strategies involving intensive interventions. TRIAL REGISTRATION NUMBER:ACTRN12616000868482.

Project description:BackgroundDepression symptoms are prevalent in the general population, and their onset and continuation may be related to biological and psychosocial factors, many of which are related to lifestyle aspects. Health promotion and lifestyle modification programmes (LMPs) may be effective on reducing the symptoms. The objective of this study was to analyse the clinical effectiveness of a LMP and a LMP plus Information and Communication Technologies, when compared to Treatment as Usual (TAU) over 6 months. The interventions were offered as an adjuvant treatment delivered in Primary Healthcare Centers (PHCs) for people with depression symptoms.MethodsWe conducted an open-label, multicentre, pragmatic, randomized clinical trial. Participants were recruited from several PHCs. Those participants visiting general practitioner for any reason, who also met the inclusion criteria (scoring 10 to 30 points on the Beck II Self-Applied Depression Inventory) were invited to take part in the study. TAU+LMP consisted of six weekly 90-min group sessions focused on improving lifestyle. TAU+LMP + ICTs replicated the TAU+LMP format, plus the addition of a wearable smartwatch to measure daily minutes walked and sleep patterns. A total of 188 participants consented to participate in the study and were randomized. We used linear mixed models, with a random intercept and an unstructured covariance to evaluate the impact of the interventions compared to TAU.ResultsBoth interventions showed a statistically significant reduction on depressive symptoms compared to TAU (TAU+LMP vs. TAU slope difference, b = -3.38, 95% CI= [-5.286, -1.474] p = 0.001 and TAU+LMP+ICTs vs. TAU slope difference, b = -4.05, 95% CI = [-5.919, -2.197], p < 0.001). These reductions imply a moderate effect size. In the TAU+LMP+ICTs there was a significant increase regarding minutes walking per week (b = 99.77) and adherence to Mediterranean diet (b = 0.702). In the TAU+LMP there was a significant decrease regarding bad sleep quality (b = -1.24).ConclusionTAU+LMPs administered in PHCs to people experiencing depression symptoms were effective on reducing these symptoms compared to TAU. They also have a positive impact on changing several lifestyle factors. These findings indicate that these interventions can be promising strategies for PHCs.

Project description:There was an increasing trend in the prevalence of obesity and its comorbidities over the past decades in Malaysia. Effective intervention for obesity remains limited. This study aimed to compare the effectiveness of a group based lifestyle modification programme amongst obese individuals with an existing dietary counseling programme.We recruited one hundred and ninety four overweight and obese (BMI>27.5 kg/m2) employees from a local university. They were randomly allocated to either Group Support Lifestyle Modification (GSLiM) (intervention)(n = 97) or dietary counseling (comparison)(n = 97). The GSLIM activities included self monitoring, cognitive-behaviour sessions, exercise as well as dietary change advocacy, which were conducted through seminars and group sessions over 24 weeks. The comparison group was given dietary counselling once in 12 weeks. Both groups were followed up for additional 12 weeks to check for intervention effect sustenance. Anthropometric and biochemical parameters were measured at baseline, 12, 24 and 36 weeks; while dietary intake, physical activities, psychological measures and quality of life measured at baseline, 24 and 36 weeks. Data analysis was conducted using ANOVA repeated measures with intention to treat principle.The participants were predominantly women with mean (standard deviation) age of 40.5 (9.3) years. A total of 19.6% of the participants in GSLiM achieved 6% weight loss compared to 4.1% in the comparison group (Risk Ratio 4.75; 95% CI: 1.68, 13.45). At 24 weeks, the retention rate was 83.5% for GSLiM and 82.5% for comparison group. GSLiM participants also achieved significant improvement in total weight self-efficacy score, negative emotions and physical discomfort subscales, MDPSS friend subscale and all domains in quality of life. Participants in the comparison group experienced reduction in negative self-thoughts.The GSLiM programme proved to be more effective in achieving targeted weight loss, improving weight self-efficacy, friend social support, and quality of life compared to dietary counseling.Iranian Registry of Clinical Trials IRCT201104056127N1.

Project description:Rising levels of obesity in South Africa require innovation in community-level lifestyle change programmes. Our aim was to co-develop Impilo neZenkolo ('Health through Faith'), a healthy lifestyle programme for low-income, black South Africans delivered through churches, and evaluate its feasibility, acceptability and potential effectiveness. In the first phase we developed programme materials with church members. In the second phase we trained lay leaders to deliver the programme and assessed feasibility, acceptability (observation, focus groups and interviews) and potential effectiveness (pre and post measurement of weight, hip and waist circumferences, blood pressure, self-reported physical activity, dietary habits, health status, self-esteem, psychological distress). The study was conducted in four churches in urban and rural South Africa. The development workshops led to increased focus on positive benefits of participation, widening inclusion criteria to all adults and greater emphasis on Christian ethos. Challenges to feasibility included: recruitment of churches; scheduling of programme sessions (leading to one church not delivering the programme); attendance at the programme (63% attended more than half of the 12 weekly sessions); and poor programme fidelity (in particular in teaching behaviour change techniques). Aspects of the programme were acceptable, particularly the way in which the programme was aligned with a Christian ethos. There was some indication that amongst the 42/68 (62%) for whom we were obtained pre- and post-programme measurements the programme has potential to support weight loss. We conclude that a healthy lifestyle programme for low-income, black South Africans, delivered through churches, may be viable with extensive re-development of delivery strategies. These include finding external funding for the programme, endorsement from national level denominational organisations and the professionalization of programme leadership, including paid rather than volunteer leaders to ensure sufficient time can be spent in training.

Project description:BackgroundUrban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address the growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate whether intensive (3-monthly) lifestyle modification advice is superior to a less-intensive (12 monthly; control group) lifestyle modification advice on a primary composite cardio-metabolic end point in 'at risk' urban subjects aged between 5-40 years.Methods/designThis is an open randomised controlled parallel group clinical trial performed at a single centre in Colombo, Sri-Lanka. A cluster sampling strategy was used to select a large representative sample of subjects aged between 5-40 years at high risk of T2DM and CVD for the intervention study. We have screened 23,298 (males 47% females 53%) healthy subjects for four risk factors: obesity, elevated waist circumference, family history of diabetes and physical inactivity, using a questionnaire and anthropometry. Those with two or more risk-factors were recruited to the intervention trial. We aim to recruit 4600 subjects for the intervention trial. The primary composite cardio-metabolic end point is; new onset T2DM, impaired glucose tolerance, impaired fasting glycaemia, new onset hypertension and albuminuria, following 5 years of intervention. The effect of the intervention on pre-specified secondary endpoints will also be evaluated. The study will be conducted according to good clinical and ethical practice, data analysis and reporting guidelines.DiscussionDIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and cardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on cardio-metabolic disease end points. This work will enable country specific and regional cardio-metabolic risk scores to be derived. Further if the proposed intervention is successful the results of this study can be translated and implemented as a low-cost primary prevention tool in Sri-Lanka and other low/middle income developing countries.Trial registrationThe trial is registered with the World Health Organisation and Sri-Lanka clinical trial registry number SLCTR/2008/003.

Dataset Information

A pragmatic lifestyle modification programme reduces the incidence of predictors of cardio-metabolic disease and dysglycaemia in a young healthy urban South Asian population: a randomised controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

A pragmatic lifestyle modification programme reduces the incidence of predictors of cardio-metabolic disease and dysglycaemia in a young healthy urban South Asian population: a randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets