Holly O'Reilly1, Chloe E Panizza2, Unhee Lim2, Kim M Yonemori2, Lynne R Wilkens2, Yurii B Shvetsov2, Michelle N Harvie3, John Shepherd2, Fengqing Maggie Zhu4, Loïc Le Marchand2, Carol J Boushey2, Kevin D Cassel5. 1. The Technological University Dublin and The University of Dublin, Trinity College, 191 North Circular Road, D07 EWV4, Dublin, Ireland. 2. University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA. 3. Manchester University Hospital Foundation NHS Trust, Cobbett House, Oxford Road, Manchester, M13 9WL, UK. 4. Purdue University, 610 Purdue Mall, West Lafayette, IN, 47907, USA. 5. University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA. kevin@cc.hawaii.edu.
Abstract
BACKGROUND: We examined the utility of self-rated adherence to dietary and physical activity (PA) prescriptions as a method to monitor intervention compliance and facilitate goal setting during the Healthy Diet and Lifestyle Study (HDLS). In addition, we assessed participants' feedback of HDLS. HDLS is a randomized pilot intervention that compared the effect of intermittent energy restriction combined with a Mediterranean diet (IER + MED) to a Dietary Approaches to Stop Hypertension (DASH) diet, with matching PA regimens, for reducing visceral adipose tissue area (VAT). METHODS: Analyses included the 59 (98%) participants who completed at least 1 week of HDLS. Dietary and PA adherence scores were collected 8 times across 12 weeks, using a 0-10 scale (0 = not at all, 4 = somewhat, and 10 = following the plan very well). Adherence scores for each participant were averaged and assigned to high and low adherence categories using the group median (7.3 for diet, 7.1 for PA). Mean changes in VAT and weight from baseline to 12 weeks are reported by adherence level, overall and by randomization arm. Participants' feedback at completion and 6 months post-intervention were examined. RESULTS:Mean ± SE, dietary adherence was 6.0 ± 0.2 and 8.2 ± 0.1, for the low and high adherence groups, respectively. For PA adherence, mean scores were 5.9 ± 0.2 and 8.5 ± 0.2, respectively. Compared to participants with low dietary adherence, those with high adherence lost significantly more VAT (22.9 ± 3.7 cm2 vs. 11.7 ± 3.9 cm2 [95% CI, - 22.1 to - 0.3]) and weight at week 12 (5.4 ± 0.8 kg vs. 3.5 ± 0.6 kg [95% CI, - 3.8 to - 0.0]). For PA, compared to participants with low adherence, those with high adherence lost significantly more VAT (22.3 ± 3.7 cm2 vs. 11.6 ± 3.6 cm2 [95% CI, - 20.7 to - 0.8]). Participants' qualitative feedback of HDLS was positive and the most common response, on how to improve the study, was to provide cooking classes. CONCLUSIONS: Results support the use of self-rated adherence as an effective method to monitor dietary and PA compliance and facilitate participant goal setting. Study strategies were found to be effective with promoting compliance to intervention prescriptions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03639350 . Registered 21st August 2018-retrospectively registered.
RCT Entities:
BACKGROUND: We examined the utility of self-rated adherence to dietary and physical activity (PA) prescriptions as a method to monitor intervention compliance and facilitate goal setting during the Healthy Diet and Lifestyle Study (HDLS). In addition, we assessed participants' feedback of HDLS. HDLS is a randomized pilot intervention that compared the effect of intermittent energy restriction combined with a Mediterranean diet (IER + MED) to a Dietary Approaches to Stop Hypertension (DASH) diet, with matching PA regimens, for reducing visceral adipose tissue area (VAT). METHODS: Analyses included the 59 (98%) participants who completed at least 1 week of HDLS. Dietary and PA adherence scores were collected 8 times across 12 weeks, using a 0-10 scale (0 = not at all, 4 = somewhat, and 10 = following the plan very well). Adherence scores for each participant were averaged and assigned to high and low adherence categories using the group median (7.3 for diet, 7.1 for PA). Mean changes in VAT and weight from baseline to 12 weeks are reported by adherence level, overall and by randomization arm. Participants' feedback at completion and 6 months post-intervention were examined. RESULTS: Mean ± SE, dietary adherence was 6.0 ± 0.2 and 8.2 ± 0.1, for the low and high adherence groups, respectively. For PA adherence, mean scores were 5.9 ± 0.2 and 8.5 ± 0.2, respectively. Compared to participants with low dietary adherence, those with high adherence lost significantly more VAT (22.9 ± 3.7 cm2 vs. 11.7 ± 3.9 cm2 [95% CI, - 22.1 to - 0.3]) and weight at week 12 (5.4 ± 0.8 kg vs. 3.5 ± 0.6 kg [95% CI, - 3.8 to - 0.0]). For PA, compared to participants with low adherence, those with high adherence lost significantly more VAT (22.3 ± 3.7 cm2 vs. 11.6 ± 3.6 cm2 [95% CI, - 20.7 to - 0.8]). Participants' qualitative feedback of HDLS was positive and the most common response, on how to improve the study, was to provide cooking classes. CONCLUSIONS: Results support the use of self-rated adherence as an effective method to monitor dietary and PA compliance and facilitate participant goal setting. Study strategies were found to be effective with promoting compliance to intervention prescriptions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03639350 . Registered 21st August 2018-retrospectively registered.
Entities:
Keywords:
Pilot study; Qualitative assessment; Randomized controlled trial; Self-rated adherence; Visceral adipose tissue; Weight loss
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