Dataset Information

Process Evaluation of the Type 2 Diabetes Mellitus PULSE Program Randomized Controlled Trial: Recruitment, Engagement, and Overall Satisfaction.

ABSTRACT:

Background

Men are underrepresented in weight loss and type 2 diabetes mellitus (T2DM) prevention studies.

Purpose

To determine the effectiveness of recruitment, and acceptability of the T2DM Prevention Using LifeStyle Education (PULSE) Program-a gender-targeted, self-administered intervention for men.

Methods

Men (18-65 years, high risk for T2DM) were randomized to intervention ( n = 53) or wait-list control groups ( n = 48). The 6-month PULSE Program intervention focused on weight loss, diet, and exercise for T2DM prevention. A process evaluation questionnaire was administered at 6 months to examine recruitment and selection processes, and acceptability of the intervention's delivery and content. Associations between self-monitoring and selected outcomes were assessed using Spearman's rank correlation.

Results

A pragmatic recruitment and online screening process was effective in identifying men at high risk of T2DM (prediabetes prevalence 70%). Men reported the trial was appealing because it targeted weight loss, T2DM prevention, and getting fit, and because it was perceived as "doable" and tailored for men. The intervention was considered acceptable, with men reporting high overall satisfaction (83%) and engagement with the various components. Adherence to self-monitoring was poor, with only 13% meeting requisite criteria. However, significant associations were observed between weekly self-monitoring of weight and change in weight ( r_s = -.47, p = .004) and waist circumference ( r_s = -.38, p = .026). Men reported they would have preferred more intervention contact, for example, by phone or email.

Conclusions

Gender-targeted, self-administered lifestyle interventions are feasible, appealing, and satisfying for men. Future studies should explore the effects of additional non-face-to-face contact on motivation, accountability, self-monitoring adherence, and program efficacy.

SUBMITTER: Aguiar EJ

PROVIDER: S-EPMC5675346 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Process Evaluation of the Type 2 Diabetes Mellitus PULSE Program Randomized Controlled Trial: Recruitment, Engagement, and Overall Satisfaction.

Aguiar Elroy J EJ Morgan Philip J PJ Collins Clare E CE Plotnikoff Ronald C RC Young Myles D MD Callister Robin R

American journal of men's health 20170419 4

<h4>Background</h4>Men are underrepresented in weight loss and type 2 diabetes mellitus (T2DM) prevention studies.<h4>Purpose</h4>To determine the effectiveness of recruitment, and acceptability of the T2DM Prevention Using LifeStyle Education (PULSE) Program-a gender-targeted, self-administered intervention for men.<h4>Methods</h4>Men (18-65 years, high risk for T2DM) were randomized to intervention ( n = 53) or wait-list control groups ( n = 48). The 6-month PULSE Program intervention focused ...[more]

PMID: 28423969

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Project description:BackgroundProcess evaluation studies are recommended to improve our understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results and on their potential transferability to practice. This paper aims to document the translation of a type-2 diabetes (T2D) prevention program into the routine context of several primary care centers, assessing process indicators related to clinician adoption, patient recruitment, exposure to the intervention components and baseline characteristics.MethodsAn observational descriptive process evaluation study was conducted of the 2.5-year implementation of the Prevention of Diabetes in Euskadi cluster randomized trial in 14 primary care centers of the Basque Health Service (Osakidetza). The clinical intervention consisted of three components: (1) risk screening, (2) an educational intervention promoting healthy lifestyles, and (3) remote support (follow-up). A passive dissemination strategy of providing training and materials was used to translate the intervention into practice. All non-diabetic patients aged 45 to 70 years who were identified as being at high risk of developing T2D were eligible for study inclusion. The RE-AIM framework guided the process evaluation.ResultsOverall, 31.4 % of family physicians and 57.6 % of nurses participated in the study, while 4170 out of 67,293 (6.2 %) targeted patients who attended the centers during the implementation period were reached through the screening. Around half of the screened patients were identified as being at high risk of developing T2D (FINDRISC score ≥14). The rate of refusal to participate and the proportion of women were higher in the intervention group. Finally, 634 and 454 non-diabetic 45- to 70-year-old patients who were at high risk of T2D were included in the control and intervention group centers (intervention reach = 48 %). Significant variability in most process indicators was observed at center level.ConclusionThe passive dissemination strategy has produced modest process indicators related to the adoption, reach and implementation of the intervention program, and reduced the possibility of its standardized application in heterogeneous contexts. The resulting different procedures and strategies used by the centers were associated with process outcomes. Context-specific variability and possible confounding will require rigorous procedures for analysis of the intervention effects.Trial registrationThe trial was registered in ClinicalTrials.gov (identifier: NCT01365013 ). Registered on June 2011.

Project description:BackgroundIn the United States, there are lower rates of breastfeeding among African American mothers, particularly those who are younger women. Recent epidemiological studies have shown a strong association of more aggressive types of breast cancer (estrogen receptor negative) among African American women, with a higher risk in African American women who did not breastfeed their children.ObjectiveThis study aims to describe the process evaluation of recruitment and educational strategies to engage pregnant African American participants for a pilot study designed to determine whether social media messaging about breast cancer risk reduction through breastfeeding may positively influence breastfeeding rates.MethodsThis pilot study is conducted in collaboration with a local Women, Infants, and Children (WIC) organization and hospital and prenatal clinics of a local health care network. To engage African American women to enroll in the study, several methods and monitoring processes were explored, including WIC electronic text-based messages sent out to all phones of current WIC recipients (referred to as e-blasts); keyword responses to texts from flyers and posters in local community-based organizations, hospitals, and prenatal clinics; keyword responses using electronic links posted in established Facebook groups; and snowball recruitment of other pregnant women by current participants through Facebook. Once enrolled, participants were randomized to 2 study conditions: (1) an intervention group receiving messages about breast cancer risk reduction and breastfeeding or (2) a control group receiving breastfeeding-only messages. Data were obtained through electronic monitoring, SurveyMonkey, qualitative responses on Facebook, focus groups, and interviews.ResultsMore than 3000 text messages were sent and received through WIC e-blasts and keyword responses from flyers. A total of 472 women were recruited through WIC e-blast, and 161 responded to flyers and contacts through the local health care network, community-based organizations, Facebook, and friend referrals. A total of 633 women were assessed for eligibility to participate in the study. A total of 288 pregnant African American women were enrolled, consented, and completed presurvey assessments (102.8% of the goal), and 22 participants attended focus groups or interviews reporting on their experiences with Facebook and the educational messages.ConclusionsThis process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women. Providing messaging and resources through social media to reinforce and educate women about breastfeeding and potentially provide lactation support is intriguing. Convenience (for researchers and participants) is an attribute of social media for this demographic of women and worthy of further research as an educational tool.Trial registrationClinicalTrials.gov NCT03680235; https://clinicaltrials.gov/ct2/show/NCT03680235.

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Project description:BackgroundChronic diseases such as type 2 diabetes mellitus and coronary heart disease cause medical, social, and economic burdens worldwide. Disease management programs in Germany mostly lack components to improve patients' self-management and health-promoting lifestyles despite clear guideline recommendations. Therefore, a Personalized Self-Management Support Program (P-SUP) was developed, which includes: (1) peer support groups; (2) telephone coaching; (3) feedback reports and, (4) a web portal. This study aims to explore patients' and implementing stakeholders' experiences in the implementation of P-SUP to identify barriers and facilitators to the implementation of the intervention.MethodsA qualitative study was conducted using face-to-face focus group interviews with participating patients and telephone-based one-to-one expert interviews with implementing stakeholders, involved in the delivery of the intervention. The transcribed interview reports were analyzed using qualitative content analysis, and the contents were categorized according to Donabedian's Structure-Process-Outcome framework.ResultsA total of six themes among patients (N = 35) and five themes among implementing stakeholders (N = 32) represent the experiences. The patient themes were: (1) technical conditions, (2) indoor facilities, (3) group composition, (4) acceptance of digital components, (5) supervision and feedback and (6) impact on lifestyle behavior. The themes among the implementing stakeholders were: (1) multiprofessional approach, (2) human resources, (3) patient acceptance, (4) supervision and feedback and (5) impact on lifestyle behavior.ConclusionsMultiprofessional interventions such as P-SUP appear to be valuable for patients and implementing stakeholders. Although infrastructural barriers made the implementation of peer support and digital patient education difficult, patients rated the exchange with peers and experts on health-related topics positively. The lack of supervision and feedback during the course of the intervention might be compensated by regular telephone coaching. The findings from this study can be used in future studies to guide researchers and implementing stakeholders and to improve the feasibility and effectiveness of complex interventions in different contexts.Trial registrationThe P-SUP study was registered in the German Clinical Trials Register (DRKS) on 16/07/2020 under the registration number DRKS00020592.

Dataset Information

Process Evaluation of the Type 2 Diabetes Mellitus PULSE Program Randomized Controlled Trial: Recruitment, Engagement, and Overall Satisfaction.

Background

Purpose

Methods

Results

Conclusions

Publications

Process Evaluation of the Type 2 Diabetes Mellitus PULSE Program Randomized Controlled Trial: Recruitment, Engagement, and Overall Satisfaction.

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