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Two for one? Effects of a couples intervention on partners of persons with Type 2 diabetes: a randomized controlled trial.

ABSTRACT: AIMS:To compare the outcomes of partners who participated in a telephone couples behavioural intervention to improve glycaemic control in persons with Type 2 diabetes with those of untreated partners of participants in an individual intervention or education; to explore 'ripple effects', i.e. positive behaviour changes seen in untreated partners. METHODS:The Diabetes Support Project was a three-arm randomized telephone intervention trial comparing outcomes of couples calls (CC), individual calls (IC) and diabetes education calls (DE). Couples included one partner with Type 2 diabetes and HbA1c ? 58 mmol/mol (7.5%). All arms received self-management education (two calls). CC and IC arms participated in 10 additional behaviour change calls. CC included partners, emphasizing partner communication, collaboration and support. Blinded assessments were performed at 4, 8 and 12 months. Partner outcomes were psychosocial (diabetes distress, relationship satisfaction, depressive symptoms), medical (BMI, blood pressure) and behavioural (fat intake, activity). RESULTS:Partners' (N = 268) mean age was 55.8 years, 64.6% were female and 29.9% were from minority ethnic groups. CC (vs. IC and DE) partners had greater reductions in diabetes distress, greater increases in marital satisfaction (4 and 8 months), and some improvements in diastolic BP. There were no consistent differences among arms in other outcomes. There was no evidence of a dietary or activity behaviour ripple effect on untreated partners, i.e. comparing partners in the IC and DE arms. CONCLUSIONS:A collaborative couples intervention resulted in significant improvements in partner diabetes distress and relationship satisfaction. There were no consistent effects on behavioural or medical partner outcomes, and no evidence of diet or activity behaviour ripple effects, suggesting that partners should be targeted directly to achieve these changes. (Clinical Trial Registry No: NCT01017523).

SUBMITTER: Trief PM

PROVIDER: S-EPMC6408270 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Two for one? Effects of a couples intervention on partners of persons with Type 2 diabetes: a randomized controlled trial.

Trief P M PM Fisher L L Sandberg J J Hessler D M DM Cibula D A DA Weinstock R S RS

Diabetic medicine : a journal of the British Diabetic Association 20190108 4

<h4>Aims</h4>To compare the outcomes of partners who participated in a telephone couples behavioural intervention to improve glycaemic control in persons with Type 2 diabetes with those of untreated partners of participants in an individual intervention or education; to explore 'ripple effects', i.e. positive behaviour changes seen in untreated partners.<h4>Methods</h4>The Diabetes Support Project was a three-arm randomized telephone intervention trial comparing outcomes of couples calls (CC), i ...[more]

PMID: 30485516

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Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).

Project description:ObjectiveTo compare glycemic control and secondary outcomes of a 4-month telephonic couples behavioral intervention to individual intervention, and to education, for adults with type 2 diabetes.Research design and methodsA randomized trial with the following three arms: couples calls (CC) (n = 104); individual calls (IC) (n = 94); and diabetes education (DE) (n = 82). All arms had self-management education (two calls). CC and IC had 10 additional behavior change calls. CC addressed collaboration and relationships/communication. Participants consisted of 280 couples, among whom one partner had type 2 diabetes and an A1C level ≥7.5%. Blinded assessments occurred at 4, 8, and 12 months. The primary outcome was change in A1C; and secondary outcomes were BMI, waist circumference, blood pressure, depressive symptoms, diabetes self-efficacy, and diabetes distress.ResultsPatients had a mean age of 56.8 years; 61.6% were male, and 30.4% were minorities. The baseline mean A1C level was 9.1%. Intention-to-treat analyses found significant A1C reductions for all (12 months: CC -0.47%, IC -0.52%, DE -0.57%), with no differences between arms. Preplanned within-arm analyses were stratified by baseline A1C tertiles: lowest tertile (7.5-8.2%), no change from baseline; middle tertile (8.3-9.2%), only CC led to significantly lower A1C level; and highest tertile (≥9.3%), significant improvement for all interventions. For BMI, CC showed significant improvement, and CC and DE led to decreased waist circumference. The IC group showed greater blood pressure improvement. Results for secondary psychosocial outcomes favored the CC group.ConclusionsIn adults with poorly controlled type 2 diabetes, a collaborative couples intervention resulted in significant, lasting improvement in A1C levels, obesity measures, and some psychosocial outcomes. For those with exceedingly high A1C levels, education alone was beneficial, but additional intervention is needed to achieve glycemic targets.

Project description:Mobile health interventions are increasingly used in health care. The level of acceptability may indicate whether and how such digital solutions will be used.This study aimed to explore associations between the level of acceptability of a mobile diabetes app and initial ability of self-management for patients with type 2 diabetes.Participants with type 2 diabetes were recruited from primary health care settings to a 3-armed randomized controlled trial in the Norwegian study in the RENEWING HEALTH project. At the 1-year follow-up, 75 out of 101 participants from the intervention groups completed an acceptability questionnaire (The Service User Technology Acceptability Questionnaire). In the randomized controlled trial, the 2 intervention groups (n=101 in total) received a mobile phone with a diabetes diary app, and one of the groups received additional health counseling given by telephone calls from a diabetes specialist nurse (n=50). At baseline, we collected clinical variables from medical records, whereas demographic data and self-management (The Health Education Impact Questionnaire) measures were self-reported. Log data from the use of the app by self-monitoring were registered continuously. Associations between initial ability to self-manage at baseline and acceptability of the diabetes diary app after 1 year were analyzed using linear regression.We found statistically significant associations between 5 of the 8 self-management domains and perceived benefit, one of the acceptability factors. However, when adjusting for age, gender, and frequency of use, only 1 domain, skill and technique acquisition, remained independently associated with perceived benefit. Frequency of use of the app was the factor that revealed the strongest association with the acceptability domain perceived benefit.Our findings indicate that persons with diabetes may accept the app, despite its perceived benefit being associated with only one of the 8 domains of their initial level of self-management.ClinicalTrials.gov NCT01315756; https://clinicaltrials.gov/show/NCT01315756 (Archived by WebCite at http://www.webcitation.org/6z46qPhWl).

Project description:BackgroundType 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity.MethodsThis was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3-6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat.ResultsThis study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight -0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference -4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI -0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study.ConclusionAmong Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being.Trial registrationClinicalTrials.gov Identified NCT00090506.

Project description:BackgroundLifestyle change is probably the most important single action to prevent type 2 diabetes mellitus. The purpose of this study was to assess the effects of a low-intensity individual lifestyle intervention by a physician and compare this to the same physician intervention combined with an interdisciplinary, group-based approach in a real-life setting.MethodsThe "Finnish Diabetes Risk score" (FINDRISC) was used by GPs to identify individuals at high risk. A randomised, controlled design and an 18 month follow-up was used to assess the effect of individual lifestyle counselling by a physician (individual physician group, (IG)) every six months, with emphasis on diet and exercise, and compare this to the same individual lifestyle counselling combined with a group-based interdisciplinary program (individual and interdisciplinary group, (IIG)) provided over 16 weeks. Primary outcomes were changes in lifestyle indicated by weight reduction ≥ 5%, improvement in exercise capacity as assessed by VO2 max and diet improvements according to the Smart Diet Score (SDS).Results213 participants (104 in the IG and 109 in the IIG group, 50% women), with a mean age of 46 and mean body mass index 37, were included (inclusion rate > 91%) of whom 182 returned at follow-up (drop-out rate 15%). There were no significant differences in changes in lifestyle behaviours between the two groups. At baseline 57% (IG) and 53% (IIG) of participants had poor aerobic capacity and after intervention 35% and 33%, respectively, improved their aerobic capacity at least one metabolic equivalent. Unhealthy diets according to SDS were common in both groups at baseline, 61% (IG) and 60% (IIG), but uncommon at follow-up, 17% and 10%, respectively. At least 5% weight loss was achieved by 35% (IG) and 28% (IIG). In the combined IG and IIG group, at least one primary outcome was achieved by 93% while all primary outcomes were achieved by 6%. Most successful was the 78% reduction in the proportion of participants with unhealthy diet (almost 50% absolute reduction).ConclusionIt is possible to achieve important lifestyle changes in persons at risk for type 2 diabetes with modest clinical efforts. Group intervention yields no additional effects. The design of the study, with high inclusion and low dropout rates, should make the results applicable to ordinary clinical settings.Trial registrationClinicalTrials.gov: NCT00202748.

Project description:INTRODUCTION:HIV transmission and acquisition risk among transgender women is particularly high in the context of primary partnerships. This project extends a previous pilot couples-focused HIV intervention programme, which was shown to be feasible, acceptable and promising in reducing sexual risk behaviour among transgender women and their partners. This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners. METHODS AND ANALYSIS:To finalise the protocol for trial, we used qualitative methods to hone eligibility criteria, refine the intervention and control manuals, and name and brand the intervention ('It Takes Two'). The RCT investigates the effects of the It Takes Two intervention on Composite Risk for HIV (CR-HIV) among 100 couples. CR-HIV is a binary indicator of couple HIV risk using validated measures of sexual behaviour, pre-exposure prophylaxis use among HIV-negative participants and viral suppression among participants living with HIV. Using a two-arm RCT, we will examine intervention effects on CR-HIV at 12-month follow-up comparing transgender women and their partners randomised to the intervention versus control (HIV prevention information only). ETHICS AND DISSEMINATION:This study has been reviewed and approved by the University of California, San Francisco (19-28624) and the University of Michigan (HUM00147690) Institutional Review Boards. Participants provide informed consent before taking part of the study activities. Results will be published in peer-reviewed journals and presented at scientific conferences. We will make our results available to the community of researchers and general public interested in transgender health to avoid unintentional duplication of research, as well as to others in the health and social services community, including LGBT community-based organisations, AIDS service organisations and other transgender-serving organisations. The full de-identified dataset and codebook will be shared at the University of Michigan Digital Repository. TRIAL REGISTRATION NUMBER:NCT04067661.

Project description:BackgroundIn 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop's digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A1c level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A1c level of 22.2 mg/dL (-0.80%). However, the added value of integrated activity trackers is unknown.ObjectiveWe conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A1c level of adults with type 1 diabetes.MethodsSocial media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop's full solution and the activity tracker, with a laboratory hemoglobin A1c level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A1c, were used to evaluate 3-month hemoglobin A1c differences in intent-to-treat (ITT) and per protocol (PP) analyses.ResultsThe enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A1c level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4).ConclusionsParticipants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A1c level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes.Trial registrationClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.

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Two for one? Effects of a couples intervention on partners of persons with Type 2 diabetes: a randomized controlled trial.

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Two for one? Effects of a couples intervention on partners of persons with Type 2 diabetes: a randomized controlled trial.

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