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Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention.

ABSTRACT: BACKGROUND:Few randomized studies have examined differential effects of group size in behavioral weight control, especially in hybrid programs that include Internet treatment approaches. METHODS:Randomized controlled trial (n = 195) comparing a 4 month hybrid internet weight loss program coupled with monthly face to face groups of 100 persons (Large Group, LG; 1 group) or to the same approach with monthly groups of 20 persons (Small Group, SG; 4 groups). Repeated-measures mixed-model analysis with age and race as covariates were used to estimate primary (weight) and secondary outcomes, and to test group differences in change over time. RESULTS:The sample was 46.3 years old ±10.4, 90.3% female, and 51.9% non-white, with BMI 37.9 ± 8.4 kg/m2. Participants in the LG were more likely to return for the 4-month assessment visit than those in the SG (p = 0.04). Participants randomized to both the LG and SG conditions experienced significant WL over time (no between group difference: -4.1 kg and -3.7 kg, respectively) and weight loss was positively associated with attendance at monthly meetings and logins to the website. Satisfaction with the program was high and similar in both groups (94.4% reported that they were "satisfied" or "very satisfied"). CONCLUSIONS:Using a hybrid approach of in-person and online weight loss interventions may be an effective way to reach larger and more diverse populations. Delivering the face to face component of the intervention in groups larger than those traditionally delivered (20-25 people) could increase the cost-effectiveness of group-based behavioral weight loss interventions. CLINICAL TRIALS REGISTRATION NUMBER:NCT01615471 . Registered June 6, 2012. Registered retrospectively.

SUBMITTER: Tate DF

PROVIDER: S-EPMC5654056 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention.

Tate Deborah F DF Valle Carmina G CG Crane Melissa M MM Nezami Brooke T BT Samuel-Hodge Carmen D CD Hatley Karen E KE Diamond Molly M Polzien Kristen K

The international journal of behavioral nutrition and physical activity 20171023 1

<h4>Background</h4>Few randomized studies have examined differential effects of group size in behavioral weight control, especially in hybrid programs that include Internet treatment approaches.<h4>Methods</h4>Randomized controlled trial (n = 195) comparing a 4 month hybrid internet weight loss program coupled with monthly face to face groups of 100 persons (Large Group, LG; 1 group) or to the same approach with monthly groups of 20 persons (Small Group, SG; 4 groups). Repeated-measures mixed-mo ...[more]

PMID: 29061153

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Project description:BackgroundObesity and visceral adiposity are associated with anovulation. The most common cause of anovulatory infertility in women of reproductive age is polycystic ovary syndrome (PCOS). We conducted this formative study to examine the effects of a remotely delivered, group-based lifestyle program for women with overweight/obesity and PCOS on ovulation, PCOS related quality of life (PCOSQ) and body composition.MethodsWomen with anovulatory infertility caused by PCOS (N = 12) were enrolled in a 6-month high-intensity weight management intervention. Participants were asked to attend 45 min., group behavioral lifestyle sessions, delivered remotely by a registered dietitian weekly across the 6-mo. study and comply with a reduced energy diet, increased physical activity (225 min/wk.), and self-monitoring of weight, physical activity and diet. Diets consisted of five portion-controlled meals (three shakes + two entrees), at least five servings of fruits/vegetables, and ad libitum non-caloric beverages daily. Wilcoxon signed-rank tests were used to assess changes in outcomes across the intervention.ResultsTwelve women received the weight loss intervention (mean age = 32.7 ± 4.2 yrs., BMI = 36.8 ± 4.5 kg/m2, 92% college educated), and 8 completed the intervention. Eight (67%) women reported ovulating during the intervention with an average time to ovulation of 57 ± 45 days. Women lost an average of 3.85 ± 5.94 kg (p = 0.02), decreased their BMI (-1.61 ± 1.09 kg/m2; p = 0.04), and waist circumference (-4.54 ± 3.03 cm; p = 0.04) over the 6-mo. intervention. Additionally, self-reported menstrual problems measured by PCOSQ significantly improved over the study (p = 0.03).ConclusionA multicomponent group-based, remotely delivered, lifestyle intervention delivered remotely is a feasible and potentially scalable option to achieve clinically relevant (>3%) weight loss in women with PCOS.Clinical trial registrationwww.clinicaltrials.gov, identifier: NCT03677362.

Project description:Electronic delivery of Screening, Brief Intervention, and Referral to Treatment (e-SBIRT) may be a low-cost and high-reach method for screening and brief intervention in health care settings. However, its relative acceptability, ability to build a therapeutic alliance, and delivery of key intervention components compared to in-person SBIRT (SBIRT) is unclear. The association of these factors with intervention outcomes is also not known. We compared SBIRT and e-SBIRT on satisfaction, alliance, and receipt of intervention components, and evaluated the extent to which these intervention dimensions were related to later substance use. Data were collected as part of a randomized clinical trial (N = 439) examining SBIRT, e-SBIRT, and enhanced usual care for childbearing-aged women in two reproductive healthcare clinics (see Martino et al. (2018) for main trial findings). Participants receiving SBIRT or e-SBIRT (N = 270) rated satisfaction and alliance following a single-session, brief intervention, based on motivational interviewing that targeted hazardous substance use (tobacco, alcohol, illicit drugs and prescribed medications). Trained raters coded audio-recorded SBIRT sessions for the presence of six major intervention components, and evaluated the occurrence of these components in the e-SBIRT software. Overall, participants in both groups reported strong satisfaction (on average, "considerably" to "extremely" satisfied) and perceived working alliance (on average, "very often" to "always" allied). SBIRT participants provided higher overall alliance ratings, felt more encouraged to make their own decisions, and rated the intervention's likely helpfulness to other women higher. Fewer e-SBIRT participants received intervention components focusing on personalized feedback, developing importance of and confidence in making changes to substance use, and developing a plan to change, compared to SBIRT participants. However, e-SBIRT participants were equally or more likely to receive components seeking to help them understand their use, discussing reasons for use, and summarizing and supporting what the patients elected to do. Notably, satisfaction, alliance, and number of intervention components received were not associated with total days of substance use. Although we found no evidence that the intervention characteristics evaluated in this study were associated with outcomes, acceptability and alliance may have other important implications. Findings suggest areas for improvement with respect to e-SBIRT satisfaction and alliance formation. ClinicalTrials.govregistration number: NCT01539525.

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Project description:ImportanceThe effectiveness of remotely delivered, self-directed, weight loss programs in routine clinical practice is largely unknown.ObjectiveTo test whether a self-directed, remotely administered behavioral lifestyle intervention improves weight and self-reported general health status compared with usual care.Design, setting, and participantsIn this randomized clinical trial, 511 adults with a body mass index (BMI) of 30 or more and less than 45 (based on electronic health record [EHR] weight and height), were enrolled from 30 Veterans Health Administration (VHA) sites between February 15, 2018, and December 18, 2018 (final follow-up February 18, 2021).InterventionsParticipants were randomly assigned to the intervention group (n = 254) or the control group (n = 257). Both received usual care. Participants randomized to the intervention received Diabetes Prevention Program-based self-directed videos, handouts, and coaching messages via an online platform or US mail for 12 months.Main outcomes and measuresCoprimary outcomes were weight measured in primary care and recorded in the EHR and self-reported general health status using the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) physical component score (PCS; higher scores are better [range, 0-100]) at the 12-month follow-up. The between-group minimal clinically important differences are 3 kg for weight and 5 points for the SF-12 PCS. Linear mixed models used weights and SF-12 PCS measured at either time point, with participants analyzed according to randomization assignment. Statistical significance for each coprimary outcome was based on a 2-sided α level of .025.ResultsAmong 511 participants randomized (mean age, 57.4 [SD, 13.9] years; 231 female [45%]), 429 (84.0%) had EHR-based weights and 410 (80.2%) had SF-12 PCS data at 12 months. The unadjusted mean weight at 12 months declined from 102.7 kg to 99.8 kg in the intervention group compared with 101.9 kg to 101.0 kg in the control group (adjusted between-group mean difference, -1.93 [97.5% CI, -3.24 to -0.61]; P = .001). At 12 months, the unadjusted mean SF-12 PCS scores declined from 44.8 to 44.3 among intervention participants compared with 44.5 to 43.2 among control participants (adjusted between-group mean difference, intervention minus control, 0.69 [97.5% CI, -1.11 to 2.49]; P = .39). Cardiovascular events represented the highest percentage of serious adverse events, accounting for 25% of events in the intervention group and 35% in the control group.Conclusions and relevanceAmong adults with obesity, a remotely delivered self-directed, behavioral lifestyle intervention, compared with usual care, resulted in statistically significantly greater weight loss at 12 months, although the difference was not clinically important. There was no significant difference in self-reported general physical health status at 12 months.Trial registrationClinicalTrials.gov Identifier: NCT03260140.

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Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention.

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Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention.

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