Project description:RationaleThe effect of weight loss on asthma in obese adults warrants rigorous investigation.ObjectivesTo examine an evidence-based, practical, and comprehensive lifestyle intervention targeting modest weight loss and increased physical activity for asthma control.MethodsThe trial randomized 330 obese adults with uncontrolled asthma to receive usual care enhanced with a pedometer, a weight scale, information about existing weight management services at the participating clinics, and an asthma education DVD, or with these tools plus the 12-month intervention.Measurements and main resultsThe primary outcome was change in Asthma Control Questionnaire (ACQ) scores from baseline to 12 months. Participants (mean [SD] age, 47.6 [12.4] yr) were 70.6% women, 20.0% non-Hispanic black, 20.3% Hispanic/Latino, and 8.2% Asian/Pacific Islander. At baseline, they were obese (mean [SD] body mass index, 37.5 [5.9] kg/m(2)) and had uncontrolled asthma (Asthma Control Test score, 15.1 [3.8]). Compared with control subjects, intervention participants achieved significantly greater mean weight loss (±SE) (intervention, -4.0 ± 0.8 kg vs. control, -2.1 ± 0.8 kg; P = 0.01) and increased leisure-time activity (intervention, 418.2 ± 110.6 metabolic equivalent task-min/wk vs. control, 178.8 ± 109.1 metabolic equivalent task-min/wk; P = 0.05) at 12 months. But between-treatment mean (±SE) differences were not significant for ACQ changes (intervention, -0.3 ± 0.1 vs. control, -0.2 ± 0.1; P = 0.92) from baseline (mean [SD], 1.4 [0.8]), nor for any other clinical asthma outcomes (e.g., spirometric results and asthma exacerbations). Among all participants regardless of treatment assignment, weight loss of 10% or greater was associated with a Cohen d effect of 0.76 and with 3.78 (95% confidence interval, 1.72-8.31) times the odds of achieving clinically significant reductions (i.e., ≥0.5) on ACQ as stable weight (<3% loss or gain from baseline). The effects of other weight change categories were small.ConclusionsModerately and severely obese adults with uncontrolled asthma can safely participate in evidence-based lifestyle intervention for weight loss and active living. The modest average weight and activity improvements are comparable to those shown to reduce cardiometabolic risk factors in studies of similar interventions in other populations but are not associated with significant net benefits for asthma control or other clinical asthma outcomes in the current population. Instead, weight loss of 10% or greater may be required to produce clinically meaningful improvement in asthma. Clinical trial registered with www.clinicaltrials.gov (NCT00901095).

Project description:ContextThe prevalence of severe obesity is increasing markedly, as is prevalence of comorbid conditions such as hypertension and type 2 diabetes mellitus; however, apart from bariatric surgery and pharmacotherapy, few clinical trials have evaluated the treatment of severe obesity.ObjectiveTo determine the efficacy of a weight loss and physical activity intervention on the adverse health risks of severe obesity.Design, setting, and participantsSingle-blind randomized trial conducted from February 2007 through April 2010 at the University of Pittsburgh. Participants were 130 (37% African American) severely obese (class II or III) adult participants without diabetes recruited from the community.InterventionsOne-year intensive lifestyle intervention consisting of diet and physical activity. One group (initial physical activity) was randomized to diet and physical activity for the entire 12 months; the other group (delayed physical activity) had the identical dietary intervention but with physical activity delayed for 6 months.Main outcome measuresChanges in weight. Secondary outcomes were additional components comprising cardiometabolic risk, including waist circumference, abdominal adipose tissue, and hepatic fat content.ResultsOf 130 participants randomized, 101 (78%) completed the 12-month follow-up assessments. Although both intervention groups lost a significant amount of weight at 6 months, the initial-activity group lost significantly more weight in the first 6 months compared with the delayed-activity group (10.9 kg [95% confidence interval {CI}, 9.1-12.7] vs 8.2 kg [95% CI, 6.4-9.9], P = .02 for group × time interaction). Weight loss at 12 months, however, was similar in the 2 groups (12.1 kg [95% CI, 10.0-14.2] vs 9.9 kg [95% CI, 8.0-11.7], P = .25 for group × time interaction). Waist circumference, visceral abdominal fat, hepatic fat content, blood pressure, and insulin resistance were all reduced in both groups. The addition of physical activity promoted greater reductions in waist circumference and hepatic fat content.ConclusionAmong patients with severe obesity, a lifestyle intervention involving diet combined with initial or delayed initiation of physical activity resulted in clinically significant weight loss and favorable changes in cardiometabolic risk factors.Trial registrationclinicaltrials.gov Identifier: NCT00712127.

Project description:BACKGROUND:Reductions in physical activity (PA) are common throughout young adulthood and low PA is associated with weight gain. The SNAP Trial previously reported that two self-regulation approaches to weight gain prevention reduced weight gain over a 2-year period in 18-35 year olds. Presented here are secondary analyses examining changes in PA and the relationship between PA and weight change over 2 years. METHODS:599 young adults (age: 27.4 ± 4.4 yrs.; BMI: 25.4 ± 2.6 kg/m2) were randomly assigned to 1 of 3 treatment arms: Small Changes (reduce calorie intake by 100 kcals/day & add 2000 steps/day), Large Changes (lose 2.3-4.5 kg initially & increase PA to ≥250 min/wk), or Self-guided (control condition). Small and Large Changes received 10, face-to-face group sessions (months 1-4), and two 4-week refresher courses each subsequent year. Body weight and PA were objectively-measured at baseline, 4 months, 1 and 2 years. Daily steps and bout-related moderate-to-vigorous intensity PA (MVPA: ≥3 METs, ≥10-min bouts) was calculated. RESULTS:Changes in bout-related MVPA and daily steps did not differ among treatment groups over the 2-year period (p's > 0.16). Collapsed across groups, participants gaining >1 lb. (n = 187; 39.6%) had smaller changes in bout-related MVPA at 4 months, 1 and 2 years relative to those maintaining or losing weight (≤1 lb. weight gain; n = 282, 60.4%, p's < 0.05). Averaged across time points, this difference equated to 47.8 min/week. Those gaining and not gaining >1 lb. did not differ on daily steps (p's > 0.10). Among participants engaging in ≥250 min/wk. of MVPA at 2 years (n = 181), 30% gained >1 lb. from baseline to 2 years, which was not different from those engaging in 150-250 min/wk. (n = 87; 36%; p = 0.40), but this percentage was significantly lower when compared to those engaging in <150 min/wk. (n = 176; 49%; p < 0.001). CONCLUSIONS:On average, PA differences were not observed between young adults assigned to small or large changes self-regulation interventions to prevent weight gain. Regardless of group assignment, higher levels of MVPA were associated with better weight gain prevention over 2 years. Our data suggest that achieving >150 min/week of MVPA is needed for weight gain prevention and that increasing MVPA, rather than steps, should be targeted. TRIAL REGISTRATION:www.clinicaltrials.gov (NCT01183689). Registered Aug 13, 2010.

Project description:BackgroundWeb-based physical activity interventions that apply computer tailoring have shown to improve engagement and behavioral outcomes but provide limited accountability and social support for participants. It is unknown how video calls with a behavioral expert in a Web-based intervention will be received and whether they improve the effectiveness of computer-tailored advice.ObjectiveThe purpose of this study was to determine the feasibility and effectiveness of brief video-based coaching in addition to fully automated computer-tailored advice in a Web-based physical activity intervention for inactive adults.MethodsParticipants were assigned to one of the three groups: (1) tailoring + video-coaching where participants received an 8-week computer-tailored Web-based physical activity intervention ("My Activity Coach") including 4 10-minute coaching sessions with a behavioral expert using a Web-based video-calling program (eg, Skype; n=52); (2) tailoring-only where participants received the same intervention without the coaching sessions (n=54); and (3) a waitlist control group (n=45). Demographics were measured at baseline, intervention satisfaction at week 9, and physical activity at baseline, week 9, and 6 months by Web-based self-report surveys. Feasibility was analyzed by comparing intervention groups on retention, adherence, engagement, and satisfaction using t tests and chi-square tests. Effectiveness was assessed using linear mixed models to compare physical activity changes between groups.ResultsA total of 23 tailoring + video-coaching participants, 30 tailoring-only participants, and 30 control participants completed the postintervention survey (83/151, 55.0% retention). A low percentage of tailoring + video-coaching completers participated in the coaching calls (11/23, 48%). However, the majority of those who participated in the video calls were satisfied with them (5/8, 71%) and had improved intervention adherence (9/11, 82% completed 3 or 4 modules vs 18/42, 43%, P=.01) and engagement (110 minutes spent on the website vs 78 minutes, P=.02) compared with other participants. There were no overall retention, adherence, engagement, and satisfaction differences between tailoring + video-coaching and tailoring-only participants. At 9 weeks, physical activity increased from baseline to postintervention in all groups (tailoring + video-coaching: +150 minutes/week; tailoring only: +123 minutes/week; waitlist control: +34 minutes/week). The increase was significantly higher in the tailoring + video-coaching group compared with the control group (P=.01). No significant difference was found between intervention groups and no significant between-group differences were found for physical activity change at 6 months.ConclusionsOnly small improvements were observed when video-coaching was added to computer-tailored advice in a Web-based physical activity intervention. However, combined Web-based video-coaching and computer-tailored advice was effective in comparison with a control group. More research is needed to determine whether Web-based coaching is more effective than stand-alone computer-tailored advice.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN): 12614000339651; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000339651+&isBasic=True (Archived by WebCite at http://www.webcitation.org/6jTnOv0Ld).

Project description:BackgroundObese individuals who have failed to achieve adequate weight loss with lifestyle changes have limited nonsurgical therapeutic options. We evaluated the efficacy and tolerability of zonisamide, an antiepileptic drug, for enhancing weight loss in obese patients receiving diet and lifestyle guidance.MethodsThis was a 1-year, randomized, double-blind, placebo-controlled trial conducted from January 9, 2006, through September 20, 2011, at Duke University Medical Center. A total of 225 obese (mean [SD] body mass index, 37.6 [4.9]) participants included 134 women (59.6%) and 91 men (40.4%) without diabetes mellitus. (Body mass index is calculated as weight in kilograms divided by height in meters squared.) Interventions were daily dosing with placebo (n = 74), 200 mg of zonisamide (n = 76), or 400 mg of zonisamide (n = 75), in addition to diet and lifestyle counseling by a dietitian for 1 year. Primary outcome was change in body weight at 1 year.ResultsOf the 225 randomized patients, 218 (96.9%) provided 1-year follow-up assessments. Change in body weight was -4.0 kg (95% CI, -5.8 to -2.3 kg; least squares mean, -3.7%) for placebo, -4.4 kg (-6.1 to -2.6 kg; -3.9%; P = .79 vs placebo) for 200 mg of zonisamide, and -7.3 kg (-9.0 to -5.6 kg; -6.8%; P = .009 vs placebo) for 400 mg of zonisamide. In the categorical analysis, 23 (31.1%) assigned to placebo, 26 (34.2%; P = .72) assigned to 200 mg of zonisamide, and 41 (54.7%; P = .007) assigned to 400 mg of zonisamide achieved 5% or greater weight loss; for 10% or greater weight loss, the corresponding numbers were 6 (8.1%), 17 (22.4%; P = .02), and 24 (32.0%; P < .001). Gastrointestinal, nervous system, and psychiatric adverse events occurred at a higher incidence with zonisamide than with placebo.ConclusionZonisamide at the daily dose of 400 mg moderately enhanced weight loss achieved with diet and lifestyle counseling but had a high incidence of adverse events.Trial registrationclinicaltrials.gov Identifier: NCT00275834

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The Impact of Health Coaching on Weight and Physical Activity in Obese Adults: A Randomized Control Trial

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