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Promoting Active Aging: Lessons Learned in an Implementation Pilot in Primary Care.
Callahan, KE, Willard, J, Foley, KL, Miller, ME, Houston, DK, Kritchevsky, SB, Williamson, JD, Applegate, WB, Girma, F, Whitehead, SE, et al
Journal of the American Geriatrics Society. 2021;(2):373-380
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Abstract
BACKGROUND Physical activity (PA) preserves mobility, but few practices screen older adults for mobility impairment or counsel on PA. DESIGN "Promoting Active Aging" (PAA) was a mixed-methods randomized-controlled pilot, to test the feasibility and acceptability of a video-based PA counseling tool and implementation into practice of two mobility assessment tools. SETTING Three primary care practices affiliated with Wake Forest Baptist Health. PARTICIPANTS Adults aged 65 years and older who presented for primary care follow-up and were willing and able to answer self-report questions and walk 4 meters (n = 59). INTERVENTION Video-based PA counseling intervention versus control video, "Healthy Eating." MEASUREMENTS Potential participants completed mobility assessments: self-report (Mobility Assessment Tool-short form (MAT-sf)) and performance based (4-meter walk test). We assessed PAA's implementation-feasibility, acceptability, and value-via interviews and surveys. Effectiveness was measured via participant attendance at a PA information session. RESULTS Of 92 patients approached, 89 (96.7%) agreed to mobility assessment. Eighty-nine completed MAT-sf, and 97.8% (87/89) completed 4-meter walk test. Sixty-seven (75%) met eligibility criteria, and 59 (88%) consented to be randomized either to the PA counseling intervention (Video-PA) or to active control (Video-C). Most participants viewed the walk test positively (51/59; 86.4%). Staff reported that completion of patient surveys, MAT-sf, and videos required significant staff time and support (median = 26 minutes for all), resulting in low acceptability of MAT-sf and the videos. Attendance at a PA information session did not differ by randomization group (Video-PA = 11/29 (37.9%); Video-C = 12/30 (40%); 95% confidence interval for difference in proportion = -0.29 to 0.25). CONCLUSIONS Mobility assessment, particularly a 4-meter walk test, was feasible in primary care. Tablet-based assessment (MAT-sf) and video counseling tools, selected to reduce staff effort, instead required significant time to implement. Future work to promote PA should identify effective ways to facilitate adoption of PA in sedentary older adults that do not burden staff.
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Lifestyle Changes Observed among Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe: The 1st Year Results of the Feel4Diabetes-Study.
Manios, Y, Lambrinou, CP, Mavrogianni, C, Cardon, G, Lindström, J, Iotova, V, Tankova, T, Rurik, I, Stappen, VV, Kivelä, J, et al
Nutrients. 2020;(7)
Abstract
The Feel4Diabetes intervention was a school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes (T2D) among families at risk of developing this disease. The current study aims to present the results on lifestyle behaviors obtained from parents during the first year of the Feel4Diabetes intervention. This multicomponent intervention had a cluster randomized design and was implemented in Belgium, Bulgaria, Finland, Greece, Hungary and Spain over two years (2016-2018). Standardized protocols and procedures were used by the participating centers in all countries to collect data on parents' lifestyle behaviors (diet, physical activity, sedentary behavior). The Feel4Diabetes intervention was registered at clinicaltrials.gov (registration number: NCT02393872). In total, 2110 high-risk parents participated in the baseline and 12-month follow-up examination measurements. Participants allocated to the intervention group reduced their daily consumption of sugary drinks (p = 0.037) and sweets (p = 0.031) and their daily screen time (p = 0.032), compared with the control group. In addition, participants in the intervention group in Greece and Spain increased their consumption of breakfast (p = 0.034) and fruits (p = 0.029), while in Belgium and Finland they increased their water intake (p = 0.024). These findings indicate that the first year of the Feel4Diabetes intervention resulted in the improvement of certain lifestyle behaviors in parents from high-risk families.
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A Randomized Controlled Trial Testing the Effectiveness of Coping with Cancer in the Kitchen, a Nutrition Education Program for Cancer Survivors.
Miller, MF, Li, Z, Habedank, M
Nutrients. 2020;(10)
Abstract
Following a diet rich in whole grains, vegetables, fruit, and beans may reduce cancer incidence and mortality. The aim of this study was to investigate the effect of Coping with Cancer in the Kitchen (CCK), an 8 week in-person program offering education, culinary demonstrations and food tasting, and psychosocial group support, compared to receiving CCK printed materials by mail on knowledge, confidence, and skills in implementing a plant-based diet. A total of 54 adult cancer survivors were randomly assigned to intervention (n = 26) and control groups (n = 27) with assessments at baseline, 9, and 15 weeks via self-administered survey. The response rate was 91% at 9 weeks and 58% at 15 weeks. The majority of our study participants were female breast cancer survivors (58%) who had overweight or obesity (65%). Compared with the control, there were significant (p < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15. There was a significant reduction in processed meat intake but changes in other food groups and psychosocial measures were modest. Participation in CCK in person increased knowledge, skills, and confidence and reduced barriers to adopting a plant-based diet. Positive trends in intake of plant-based foods and quality of life warrant further investigation in larger-scale studies and diverse populations.
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Prevention of Metabolic Syndrome by Telephone-Delivered Lifestyle Intervention in a Real-World Setting: Sub-Analysis of a Cluster-Randomized Trial.
Sakane, N, Kotani, K, Suganuma, A, Takahashi, K, Sato, J, Suzuki, S, Izumi, K, Kato, M, Noda, M, Nirengi, S, et al
Metabolic syndrome and related disorders. 2019;(7):355-361
Abstract
Background: Evidence of the long-term benefits of telephone-delivered lifestyle interventions is limited. This study investigated the ability of telephone-delivered lifestyle intervention to reduce the incidence of metabolic syndrome (MetS) in subjects diagnosed with impaired fasting glucose (IFG) during health checkups. Methods: Our subjects were participants in the Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a prospective, cluster-randomized controlled trial designed to investigate whether goal-focused lifestyle coaching over the telephone can effectively reduce the incidence of type 2 diabetes development in high-risk individuals in a primary health care setting. We extracted 753 and 844 J-DOIT1 participants from the intervention and controls arms, respectively, who had IFG but did not meet the MetS criteria at baseline. The intervention arm received goal-focused lifestyle support delivered by health care providers via telephone over a 1-year period. The endpoint was the development of incident MetS, defined based on the Adult Treatment Panel III criteria modified for Japan. Results: During the median follow-up period of 4.9 years, 8.0% of the intervention arm and 12.0% of the control arm developed MetS. Overall, the hazard ratio (HR) for the development of MetS was 0.75 [95% confidence interval (CI), 0.52-1.09; P = 0.14] in the intervention arm. However, the HR in overweight or obese [body mass index (BMI) ≥23 kg/m2] individuals was significantly reduced to 0.63 (95% CI, 0.41-0.95; P = 0.029), but not in lean (BMI <23 kg/m2) individuals. Conclusion: Telephone-delivered lifestyle intervention effectively reduced the incidence of MetS in overweight and obese subjects in a real-world setting. Clinical trial registration number: UMIN000000662 (registered March 30, 2007; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000000798).
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Cost-effectiveness of telephone coaching for physically inactive ambulatory care hospital patients: economic evaluation alongside the Healthy4U randomised controlled trial.
Barrett, S, Begg, S, O'Halloran, P, Kingsley, M
BMJ open. 2019;(12):e032500
Abstract
OBJECTIVE To assess whether telephone coaching is a cost-effective method for increasing physical activity and health-related quality of life for insufficiently active adults presenting to an ambulatory care clinic in a public hospital. DESIGN An economic evaluation was performed alongside a randomised controlled trial. SETTING Participants were recruited from an ambulatory care clinic in a public hospital in regional Australia. PARTICIPANTS Seventy-two adults (aged 18-69) deemed insufficiently physically active via self-report. INTERVENTIONS Participants were randomised to either an intervention group that received an education session and eight sessions of telephone coaching over a 12-week period, or to a control group that received the education session only. The intervention used in the telephone coaching was integrated motivational interviewing and cognitive behavioural therapy. OUTCOME MEASURES The primary health outcome was change in moderate-to-vigorous physical activity (MVPA), objectively measured via accelerometry. The secondary outcome was the quality-adjusted life-year (QALY) determined by the 12-item Short Form Health Survey Questionnaire. Outcome data were measured at baseline, postintervention (3 months) and follow-up (6 months). Incremental cost-effectiveness ratios (ICERs) were calculated for each outcome. Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty. RESULTS The mean intervention cost was $279±$13 per person. At 6 months follow-up, relative to control, the intervention group undertook 18 more minutes of daily MVPA at an ICER of $15/min for each additional minute of MVPA. With regard to QALYs, the intervention yielded an ICER of $36 857 per QALY gained. Sensitivity analyses indicated that results were robust to varied assumptions. CONCLUSION Telephone coaching was a low-cost strategy for increasing MVPA and QALYs in insufficiently physically active ambulatory care hospital patients. Additional research could explore the potential economic impact of the intervention from a broader healthcare perspective. TRIAL REGISTRATION NUMBER ANZCTR ACTRN12616001331426.
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A randomized controlled trial of orthodontist-based brief advice to prevent child obesity.
Hovell, MF, Schmitz, KE, Liles, S, Robusto, K, Hofstetter, CR, Nichols, JF, Rock, CL, Irvin, V, Parker, MS, Surillo, SA, et al
Contemporary clinical trials. 2018;:53-61
Abstract
OBJECTIVE We conducted a randomized controlled trial to test whether brief exercise and diet advice provided during child patient visits to their orthodontic office could improve diet, physical activity, and age-and-gender-adjusted BMI. METHODS We enrolled orthodontic offices in Southern California and Tijuana, Mexico, and recruited their patients aged 8-16 to participate in a two-year study. At each office visit, staff provided the children with "prescriptions" for improving diet and exercise behaviors. Multilevel models, which adjusted for clustering, determined differential group effects on health outcomes, and moderation of effects. RESULTS We found differential change in BMI favoring the intervention group, but only among male participants (p < 0.001; Cohen's d = 0.085). Of four dietary variables, only junk food consumption changed differentially, in favor of the intervention group (p = 0.020; d = 0.122); the effect was significant among overweight/obese (p = 0.001; d = 0.335) but not normal weight participants. Physical activity declined non-differentially in both groups and both genders. CONCLUSION The intervention, based on the Geoffrey Rose strategy, had limited success in achieving its aims. IMPLICATIONS Orthodontists can deliver non-dental prevention advice to complement other health-practitioner-delivered advice. Higher fidelity to trial design is needed to adequately test the efficacy of clinician-based brief advice on preventing child obesity and/or reversing obesity.
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Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States.
McElfish, PA, Long, CR, Kaholokula, JK, Aitaoto, N, Bursac, Z, Capelle, L, Laelan, M, Bing, WI, Riklon, S, Rowland, B, et al
Medicine. 2018;(19):e0677
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Abstract
BACKGROUND Pacific Islander populations, including Marshallese, face a disproportionately high burden of health disparities relative to the general population. OBJECTIVES A community-based participatory research (CBPR) approach was utilized to engage Marshallese participants in a comparative effectiveness trial testing 2 Diabetes Prevention Program (DPP) interventions designed to reduce participant's weight, lower HbA1c, encourage healthy eating, and increase physical activity. DESIGN To compare the effectiveness of the faith-based (WORD) DPP to the culturally adapted (Pacific Culturally Adapted Diabetes Prevention Program [PILI]) DPP, a clustered randomized controlled trial (RCT) with 384 Marshallese participants will be implemented in 32 churches located in Arkansas, Kansas, Missouri, and Oklahoma. Churches will be randomly assigned to WORD DPP arm or to PILI DPP arm. METHODS WORD DPP focuses on connecting faith and health to attain a healthy weight, eat healthy, and be more physically active. In contrast, PILI DPP is a family and community focused DPP curriculum specifically adapted for implementation in Pacific Islander communities. PILI focuses on engaging social support networks to maintain a healthy weight, eat healthy, and be more physically active. All participants are assessed at baseline, immediate post intervention, and 12 months post intervention. SUMMARY Both interventions aim to cause weight loss through improving physical activity and healthy eating, with the goal of preventing the development of T2D. The clustered RCT will determine which intervention is most effective with the Marshallese population. The utilization of a CBPR approach that involves local stakeholders and engages faith-based institutions in Marshallese communities will increase the potential for success and sustainability. This study is registered at clinicaltrials.gov (NCT03270436).
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The marketing plan and outcome indicators for recruiting and retaining parents in the HomeStyles randomized controlled trial.
Byrd-Bredbenner, C, Delaney, C, Martin-Biggers, J, Koenings, M, Quick, V
Trials. 2017;(1):540
Abstract
BACKGROUND Despite the critical importance of successful recruitment and retention to study integrity, reporting of recruitment and retention strategies along with factors associated with successful recruitment and retention of participants in health-related interventions remain rare, especially for health and obesity prevention programs. Thus, the purpose of this article is to retrospectively examine the recruitment and retention marketing plan used in the online HomeStyles randomized controlled trial (RCT) and discuss outcomes associated with completion of the intervention. METHODS The HomeStyles RCT is an online intervention developed to motivate parents of young children to gain the skills and self-confidence needed to shape home environments and lifestyles to be protective against childhood obesity. Using the seven Ps of services marketing (i.e., people, place, product, physical evidence, price, promotion, and process), a comprehensive and systematic plan for recruitment and retention was implemented and outcomes assessed. RESULTS A total of 489 parents with a young child aged 2 to < 6 years were eligible to participate, a final capture rate of 33%. Only 23% of Hispanic participants chose to use the Spanish-language version of HomeStyles intervention materials, below the demand anticipated. However, Hispanic enrollment overall was substantially higher than the U.S. population proportion (i.e., 17%). The number of participants prematurely leaving the study was similar in both treatment groups, indicating attrition was not differential. Completers reported high satisfaction of HomeStyles, using a 1-5 scale (strongly disagree to strongly agree) on guide attractiveness, interestingness, and usefulness. Despite all the retention efforts, the average monthly recruitment accrual rate of ~ 33 eligible enrolled participants at baseline (i.e., 489 participants/15-month recruitment period), declined to ~ 18, 11, 9, and 8 remaining recruited participants/month at midpoint, post, follow-up, and long-term follow-up surveys, respectively. In general, survey completers were significantly more likely to be female and perceived their child's health status to be better, and they were significantly less likely to be restrictive of their child's food intake. CONCLUSIONS The findings of the present study highlight the need for far-reaching, concentrated, and varied recruitment strategies; sufficient time in the research plan for recruitment and retention activities; and creative, tireless, flexible, persistent project staff for health-related interventions.
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Three-year follow-up of a randomised controlled trial to reduce excessive weight gain in the first two years of life: protocol for the POI follow-up study.
Taylor, RW, Heath, AL, Galland, BC, Cameron, SL, Lawrence, JA, Gray, AR, Tannock, GW, Lawley, B, Healey, D, Sayers, RM, et al
BMC public health. 2016;(1):771
Abstract
BACKGROUND The Prevention of Overweight in Infancy (POI) study was a four-arm randomised controlled trial (RCT) in 802 families which assessed whether additional education and support on sleep (Sleep group); food, physical activity and breastfeeding (FAB group); or both (Combination group), reduced excessive weight gain from birth to 2 years of age, compared to usual care (Control group). The study had high uptake at recruitment (58 %) and retention at 2 years (86 %). Although the FAB intervention produced no significant effect on BMI or weight status at 2 years, the odds of obesity were halved in those who received the sleep intervention, despite no apparent effect on sleep duration. We speculate that enhanced self-regulatory behaviours may exist in the Sleep group. Self-regulation was not measured in our initial intervention, but extensive measures have been included in this follow-up study. Thus, the overall aim of the POI follow-up is to determine the extent to which augmented parental support and education on infant sleep, feeding, diet, and physical activity in the first 2 years of life reduces BMI at 3.5 and 5 years of age, and to determine the role of self-regulation in any such relationship. METHODS/DESIGN We will contact all 802 families and seek renewed consent to participate in the follow-up study. The families have received no POI intervention since the RCT finished at 2 years of age. Follow-up data collection will occur when the children are aged 3.5 and 5 years (i.e. up to 3 years post-intervention). Outcomes of interest include child anthropometry, body composition (DXA scan), diet (validated food frequency questionnaire), physical activity (accelerometry), sleep (questionnaire and accelerometry), and self-regulation (questionnaires and neuropsychological assessment). DISCUSSION Our follow-up study has been designed primarily to enable us to determine whether the intriguing benefit of the sleep intervention suggested at 2 years of age remains as children approach school age. However, cohort analyses will also investigate how BMI, self-regulation, and sleep consolidation develop during the early years. This information will be valuable to researchers and policy makers progressing the field of early childhood obesity prevention. TRIAL REGISTRATION ClinicalTrials.gov number NCT00892983 .
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Elearning approaches to prevent weight gain in young adults: A randomized controlled study.
Nikolaou, CK, Hankey, CR, Lean, ME
Obesity (Silver Spring, Md.). 2015;(12):2377-84
Abstract
OBJECTIVE Preventing obesity among young adults should be a preferred public health approach given the limited efficacy of treatment interventions. This study examined whether weight gain can be prevented by online approaches using two different behavioral models, one overtly directed at obesity and the other covertly. METHODS A three-group parallel randomized controlled intervention was conducted in 2012-2013; 20,975 young adults were allocated a priori to one control and two "treatment" groups. Two treatment groups were offered online courses over 19 weeks on (1) personal weight control ("Not the Ice Cream Van," NTICV) and, (2) political, environmental, and social issues around food ("Goddess Demetra," "GD"). Control group received no contact. The primary outcome was weight change over 40 weeks. RESULTS Within-group 40-week weight changes were different between groups (P < 0.001): Control (n = 2,134): +2.0 kg (95% CI = 1.5, 2.3 kg); NTICV (n = 1,810): -1.0 kg (95% CI = -1.3, -0.5); and GD (n = 2,057): -1.35 kg (95% CI = -1.4 to -0.7). Relative risks for weight gain vs. CONTROL NTICV = 0.13 kg (95% CI = 0.10, 0.15), P < 0.0001; GD = 0.07 kg (95% CI = 0.05, 0.10), P < 0.0001. CONCLUSIONS Both interventions were associated with prevention of the weight gain observed among control subjects. This low-cost intervention could be widely transferable as one tool against the obesity epidemic. Outside the randomized controlled trial setting, it could be enhanced using supporting advertising and social media.