A Mindfulness-Based Intervention to Control Weight After Bariatric Surgery: Preliminary Results From a Randomized Controlled Pilot Trial

Borderline on S3 (load-bearing), S4 (based): unclear from the text.

Two adverse events related to the mindfulness-based intervention were reported.

“Two adverse events related to the MBI were reported.”

May combine two claims.

All seven participants reported improved eating behaviors; healthier food choices were most common, followed by portion control, planning ahead, and moderation or restraint for most.

“Similarly, all 7 participants reported improvements in eating behaviors, with ‘healthier food choices’ most commonly mentioned, followed by ‘portion control’, ‘planning ahead’, and ‘moderation and restraint’ mentioned by the majority.”

May combine two claims.

There was no significant between-group difference in weight change at 12 weeks or 6 months, although weight tended to increase in the mindfulness group.

“We observed no significant between-group difference in changes in weight at 12 weeks and 6 months, although trends suggested an increase in weight in the mindfulness group.”

May combine two claims.

All seven participants reported greater awareness of eating patterns, bodily cues, and environmental triggers, and most reported greater self-care.

“Likewise, all 7 participants reported greater awareness of eating patterns, bodily cues, and environmental triggers, and the majority mentioned greater self-care.”

May combine two claims.

Qualitative reports of reduced stress and improved coping conflicted with quantitative measures showing increased stress at 12 weeks and no change in coping.

“Regarding stress and coping ability, we observed an intriguing discordance between our qualitative and quantitative findings where participants reported reduced stress and improved coping in qualitative interviews, but on objective measures of stress and coping, they reported a significant increase in stress at 12 weeks and no change in coping.”

May combine two claims.

Binge eating did not improve significantly; there was a trend toward a marginal increase at 12 weeks that disappeared by 6 months.

“but a trend toward a marginal increase in binge eating at 12 weeks that dissipated at 6 months (Table 2).”

• Also stated in: § Discussion · plain

  “In contrast to prior studies,27,29–32 we did not observe a significant improvement in binge eating.”

May combine two claims.

Participants all emphasized the group's importance, including hearing others' experiences, trust and safety, and cohesion and friendship.

“Participants universally highlighted the importance of the group, specifically the benefit of hearing others’ experiences, trust and safety, and cohesion and friendship.”

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In qualitative interviews, all seven participants reported reduced stress reactivity, better coping with life struggles, calm and peace, and greater perspective.

“In contrast to quantitative data, all 7 participants reported reduced stress reactivity, including the ability to cope more effectively with life’s struggles, feelings of calm and peace, and a greater sense of perspective.”

May combine two claims.

Despite challenges such as difficulty sitting still and finding time to meditate, all seven participants reported strong self-efficacy for maintaining lifestyle changes.

“Although participants expressed challenges including difficulty sitting still and finding time for meditation, all 7 participants reported a strong sense of self-efficacy regarding maintaining lifestyle changes.”

May combine two claims.

Participants reported high satisfaction and perceived benefit from the mindfulness-based intervention, and they wanted continued mindfulness support.

“Patients reported high satisfaction and overall benefit of the MBI.”

• Also stated in: § Qualitative Data · plain

  “Participants universally reported high acceptability and perceived benefit of the intervention, as well as a desire for continued mindfulness support.”

May combine two claims.

Six of nine mindfulness participants attended at least 7 of 10 classes, while two attended fewer than 5 because of unexpected life circumstances.

“Attendance was excellent (6 of 9 patients attended ≥ 7 of 10 classes).”

• Also stated in: § Measures of Feasibility and Acceptability · plain

  “Six of nine patients attended ≥ 7 of 10 mindfulness classes; two patients attended < 5 classes due to unexpected life circumstances.”

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All participants completed every follow-up visit and were included in the intention-to-treat analysis.

“100% completed all study follow-up visits and were included in the intention-to-treat analysis.”

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Of 43 screened patients, 31 were eligible and 18 (58%) were willing and able to participate; recruitment was just below the target of 20, mainly because of scheduling conflicts.

“Of 43 patients screened, 31 were eligible to participate. Of these, 18 (58%) were willing and able to participate. Our recruitment numbers (n=18) were just below our target of 20, primarily due to scheduling conflicts.”

May combine two claims.

Trends in inflammatory biomarkers were unclear and not statistically significant.

“Trends in inflammatory biomarkers were less clear and not statistically significant.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

One participant had surfacing of repressed memories and depression during the intervention, was referred for counseling, continued attending and meditating, and said mindfulness helped her cope with the traumatic memories.

“Another participant experienced surfacing of repressed memories and depression during the MBI and was referred to a social worker for counseling. She continued attending classes and practicing meditation and stated the mindfulness helped her to cope with the traumatic memories.”

Probably not a substantial claim: may not pass S1 (asserted), S4 (based).

All primary analyses were performed on an intention-to-treat basis.

“All primary analyses were performed on an intention-to-treat basis.”

May combine two claims.

The intervention did not improve weight or glycemic control in the short term.

“although it did not improve weight or glycemic control in the short term.”

• Also stated in: § Discussion · plain

  “In this study, we did not see a significant difference in weight change. Rather, we observed a slight trend toward increased weight and a statistically significant, modest increase in HbA1C levels.”

May combine two claims.

In bariatric patients, emotional eating has been reported as an important contributor to weight gain and a risk factor for poor post-surgical outcomes.

“Among bariatric patients, emotional eating has been reported as an important factor contributing to weight gain25 and a risk factor for poor post-surgical outcomes.26”

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Psychological and behavioral factors are widely thought to play a major role in weight regain, and patients with worse psychological outcomes after surgery may be more likely to regain weight.

“Although factors driving weight regain are not fully understood, it is widely believed that psychological and behavioral factors play a major role.3 Studies suggest weight regain is more likely among patients who fare worse psychologically after surgery.3”

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The discordance may reflect different ways of conceptualizing stress and coping: participants may have gained the ability to step back but also became more aware of stressors, and mindfulness awareness can itself be stressful.

“This discordance may reflect the different ways stress and coping can be conceptualized. While participants may have experienced a greater ability to step back and not react immediately, as reported qualitatively, they may also have become more aware of their stressors. Mindfulness involves bringing awareness to behavioral and emotional patterns, both positive and negative, which can be, paradoxi”

• AssumptionRests on an assumption: Mindfulness brings awareness to positive and negative behavioral and emotional patterns, and this awareness can itself be stressful.

May combine two claims.

The lack of binge eating improvement may be partly because baseline binge eating was lower than in nonsurgical populations, possibly due to presurgical screening and exclusion, and because the altered anatomy after surgery makes continued binge eating physically difficult.

“This may be, in part, because baseline levels of binge eating in our sample were lower than in nonsurgical populations likely because bariatric patients are screened for binge eating and potentially excluded before surgery. Furthermore, it is physically difficult for patients to continue binge eating after surgery due to a smaller gastric pouch and narrowed gastric outlet.”

• AssumptionRests on an assumption: Bariatric surgery candidates are screened for binge eating and may be excluded before surgery.
• AssumptionRests on an assumption: After bariatric surgery, the smaller gastric pouch and narrowed gastric outlet make continued binge eating physically difficult.

May combine two claims.

The pilot trial lacked a time-matched control group, so the specific effects of mindfulness cannot be separated from standard behavioral therapy or from group time.

“Given the nature of this pilot trial, we did not have a time-matched control group so we cannot disentangle specific effects of mindfulness from standard behavioral therapy or the effect of time spent in a group.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Some studies have reported relaxation-induced anxiety, in which anxiety symptoms increase during meditation and relaxation practices.

“In addition, some studies have reported a phenomenon of ‘relaxation-induced anxiety’ whereby anxiety symptoms increase during meditative and relaxation practices.40”

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May combine two claims.

Mindfulness-based approaches offer a systematic method of stress reduction and may be especially suitable for bariatric patients who face high levels of obesity-related stigma, discrimination, and social bias.

“Mindfulness-based approaches, in contrast, provide a systematic method of stress reduction that may be particularly well suited for bariatric patients who face unusually high levels of obesity-related stigma, discrimination, and social bias.5,6”

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Probably not a substantial claim: may not pass S3 (load-bearing).

Randomization was stratified by surgery type.

“Randomization was stratified by surgery type.”

May combine two claims.

Findings on weight loss after mindfulness are mixed, with some studies but not all reporting weight improvements.

“Findings on weight loss after mindfulness have been mixed, with some31–37 but not all38,39 studies reporting improvements in weight.”

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May combine two claims.

Baseline characteristics were reviewed for approximate balance across groups, and surgery types were well balanced.

“Baseline characteristics were reviewed to ensure approximate balance across groups.”

• Also stated in: § Baseline Characteristics · boosted

  “Surgery types were well balanced across groups.”

Classified as probably not a substantial claim. May combine two claims.

Mindfulness is hypothesized to help weight loss through greater awareness of unhealthy behavioral patterns, recognition of internal hunger and satiety cues, and improved coping skills.

“Mindfulness is hypothesized to facilitate weight loss through several mechanisms including greater awareness of unhealthy behavioral patterns, recognition of internal hunger and satiety cues, and improved coping skills.12”

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May combine two claims.

Traditional behavioral strategies using diet, physical activity, and behavioral modification work in the short term but generally do not maintain weight loss long term and are not effective in severe obesity.

“Traditional behavioral strategies incorporating diet, physical activity, and behavioral modification, although effective in the short term, are generally not successful in maintaining weight loss in the long term and are not effective in patients with severe obesity.4”

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May combine two claims.

For patients with deeply rooted psychological issues, mindfulness may uncover those issues and, in the short term, intensify psychological symptoms and worsen eating behaviors and weight loss.

“This case highlights an important nuance of mindfulness in the treatment of obesity. For patients with deeply rooted psychological issues, mindfulness may help to uncover these issues, yet in doing so, may intensify psychological symptoms in the short-term and adversely affect eating behaviors and weight loss.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Treatment assignments were sealed in sequentially numbered opaque envelopes and opened by study staff only after baseline testing.

“Treatment assignments were sealed in sequentially-numbered, opaque envelopes. Randomization was stratified by surgery type. Study staff opened sealed envelopes immediately after baseline testing to determine the final treatment assignment.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The randomization sequence was generated in SAS by the study statistician using permuted blocks with randomly varying block sizes.

“Treatment assignments for randomization were generated in SAS by the study statistician using permuted blocks with randomly-varying block sizes.”

Classified as probably not a substantial claim. May combine two claims.

Emerging research suggests acceptance and mindfulness-based approaches may reduce emotional and binge eating, and early mixed evidence suggests possible promise for weight control.

“Emerging research suggests acceptance and mindfulness-based approaches may be effective for reducing emotional and binge eating,11 and early evidence, although mixed, suggests promise for weight control.12”

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Sensitivity analyses excluded two mindfulness participants who attended fewer than five classes and one who had surfacing of repressed traumatic memories.

“We conducted sensitivity analyses including a ‘completers analysis’ excluding two mindfulness participants who attended <5 classes and an analysis excluding one mindfulness participant who experienced surfacing of repressed traumatic memories.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Mindfulness-based approaches have shown clinical effectiveness for chronic pain, stress, depression, and anxiety.

“Mindfulness-based approaches have been shown clinically to be effective for chronic pain,8 stress,9 depression,10 and anxiety.10”

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Classified as probably not a substantial claim. May combine two claims.

Weight regain is common after bariatric surgery, usually begins 1-2 years afterward, and about 30% of patients regain weight at 18 months to 2 years.

“yet weight regain is common and typically begins 1–2 years post-surgery. Approximately 30% of patients regain weight at 18 months to 2 years after surgery2”

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May combine two claims.

The trial was a small pilot with limited power to detect clinically meaningful changes, so the findings are preliminary.

“This was a small pilot trial with limited power to detect clinically meaningful changes, thus our findings should be considered preliminary.”

May combine two claims.

Linear mixed models with covariates were used to account for possible baseline confounding, and the time-by-group estimates did not change substantially.

“To account for potential confounding by variables imbalanced at baseline, we performed a series of linear mixed models. The base model included time and group, the interaction between time and group, and an autoregressive covariance matrix. We added covariates (baseline weight, depression, stress, emotional and uncontrolled eating, time since surgery) to the model individually and examined the”

Probably not a substantial claim: may not pass S3 (load-bearing).

One study reported improvement in binge eating after mindfulness training following surgery.

“That said, one study reported an improvement in binge eating after mindfulness training post-surgery,27 so further exploration is warranted.”

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Probably not a substantial claim: may not pass S3 (load-bearing).

A randomized study of an internet-based acceptance-based intervention for disordered eating after surgery improved emotional eating after six weeks.

“Similarly, a randomized study of an internet-based acceptance-based intervention targeting disordered eating post-surgery improved emotional eating after six weeks.28”

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