# Abstract

 

## OBJECTIVE After intensive insulin treatment, many obese African American patients with new-onset diabetic ketoacidosis (DKA) and severe hyperglycemia are able to achieve near-normoglycemia remission. The optimal treatment to prevent hyperglycemic relapses after remission is not known. 

## RESEARCH DESIGN AND METHODS This prospective, 4-year, placebo-controlled study randomly assigned 48 African American subjects with DKA and severe hyperglycemia to metformin 1,000 mg daily (*n* = 17), sitagliptin 100 mg daily (*n* = 16), or placebo (*n* = 15) after normoglycemia remission. Hyperglycemic relapse was defined as fasting glucose >130 mg/dL (7.2 mmol/L) and HbA~1c~ >7.0% (53 mmol/mol). Oral glucose tolerance tests were conducted at randomization and at 3 months and then every 6 months for a median of 331 days. Oral minimal model and incremental area under the curve for insulin (AUCi) were used to calculate insulin sensitivity (Si) and β-cell function, respectively. Disposition index (DI) was calculated as a product of Si and incremental AUCi. 

## RESULTS Relapse-free survival was higher in sitagliptin and metformin (*P* = 0.015) compared with placebo, and mean time to relapse was significantly prolonged in the metformin and sitagliptin groups compared with the placebo group (480 vs. 305 days, *P* = 0.004). The probability of relapse was significantly lower for metformin (hazard ratio 0.28 [95% CI 0.10--0.81]) and sitagliptin (0.31 [0.10--0.98]) than for placebo. Subjects who remained in remission had a higher DI (*P* = 0.02) and incremental AUCi (*P* < 0.001) than those with hyperglycemia relapse without significant changes in Si. 

## CONCLUSIONS This study shows that near-normoglycemia remission was similarly prolonged by treatment with sitagliptin and metformin. The prolongation of remission was due to improvement in β-cell function. # Results Forty-eight African American subjects with DKA (*n* = 22) and severe hyperglycemia (*n* = 26) were included in the study. Seventeen subjects were randomly assigned to metformin 1,000 mg daily, 16 to sitagliptin 100 mg daily, and 15 to placebo. Four subjects in the metformin group, 6 in the sitagliptin group, and 1 in the placebo group were lost to follow-up. One subject in the sitagliptin group and one subject in the placebo group withdrew from the study. The overall median follow-up after insulin discontinuation was 331 days (interquartile range 102, 612 days) with no differences between randomized groups ([Table 1](#)). The subjects lost to follow-up or who withdrew from the study were in near-normoglycemia remission during their last documented study visit. There were no significant differences in baseline characteristics at presentation between subjects who withdrew and those who stayed in the study, except for HbA~1c~. HbA~1c~ was lower at presentation of DKA/hyperglycemia in subjects who withdrew compared with those who stayed (12.0 ± 2.3% [107 ± 25 mmol/mol] vs. 13.5 ± 2.0% [124 ± 22 mmol/mol], *P* = 0.03) but was similar at randomization. ::::table-wrap

::: caption
Clinical characteristics of obese African American subjects with DKA and
severe hyperglycemia
:::

```
                                       Metformin (*n* = 17)   Sitagliptin (*n* = 16)   Placebo (*n* = 15)   *P* value
```

______________________________________________________________________

Sex (*n*) 0.70
Male 11 11 8\
Female 6 5 7\
Age (years) 48 ± 9 50 ± 11 46 ± 13 0.73
At diagnosis of diabetes\
BMI (kg/m^2^) 35.0 ± 4.3 37.3 ± 10.0 34.9 ± 5.2 0.96
DKA/severe hyperglycemia (*n*) 7/10 10/6 5/10 0.26
Family history of type 2 diabetes (%) 71 88 80 0.56
FBG 0.49
mmol/L 40.8 ± 13.5 41.7 ± 18.7 43.7 ± 12.2\
mg/dL 735 ± 243 750 ± 336 787 ± 219\
GAD antibody positivity \[*n* (%)\] 2 (12) 0 (0)[\*](#) 3 (23)[\*](#) 0.20
HbA~1c~ 0.85
% 13.1 ± 2.0 13.1 ± 2.5 13.1 ± 2.3\
mmol/mol 120 ± 21 120 ± 27 120 ± 25\
Fasting C-peptide (pg/L) 2.8 ± 1.1 3.4 ± 1.2 3.1 ± 1.2 0.43
At randomization\
FBG 0.21
mmol/L 6.3 ± 1.0 6.2 ± 0.9 7.0 ± 1.3\
mg/dL 114 ± 18 111 ± 16 125 ± 24\
HbA~1c~ 0.28
% 6.2 ± 0.9 6.5 ± 0.7 6.6 ± 0.5\
mmol/mol 44 ± 10 48 ± 8 49 ± 6\
Insulin dose (units/kg/day) 0.5 ± 0.2 0.6 ± 0.3 0.8 ± 0.4 0.08
Length of insulin use (weeks) 9.5 ± 3.0 7.6 ± 3.2 9.2 ± 2.7 0.14
ΔWeight from enrollment (kg) 1.8 (−1.0, 5.9) −0.1 (−3.5, 5.1) −4.6 (−6.3, 0.5) 0.08
At end of study---all subjects\
Duration of treatment[†](#) (days) 472 (242, 716) 194 (92, 613) 194 (91, 579) 0.19
ΔWeight from randomization (kg) 0 (−3.6, 3.5) 3.3 (−0.7, 6.0) 1.4 (−2.2, 2.9) 0.10
FBG 0.10
mmol/L 6.7 ± 1.2 6.9 ± 1.5 8.5 ± 3.2\
mg/dL 121 ± 22 124 ± 27 153 ± 58\
HbA~1c~ 0.04
% 6.4 ± 1.2 6.6 ± 1.1 7.6 ± 1.6\
mmol/mol 46 ± 13 48 ± 12 55 ± 22\
Near-normoglycemia remission (*n*) 12 12 4\
End-of-study FBG 0.04
mmol/L 6.2 ± 1.1 6.1 ± 0.4 7.4 ± 0.8\
mg/dL 112 ± 19 110 ± 7 134 ± 15\
End-of-study HbA~1c~ 0.80
% 5.8 ± 0.7 6.1 ± 0.7 6.1 ± 0.5\
mmol/mol 40 ± 8 43 ± 8 43 ± 6\
Hyperglycemia relapse (*n*) 5 4 11\
End-of-study FBG 0.51
mmol/L 7.9 ± 0.4 9.1 ± 1.3 8.9 ± 3.8\
mg/dL 142 ± 7 163 ± 23 160 ± 68\
End-of-study HbA~1c~ 0.94
% 8.0 ± 0.9 8.0 ± 0.9 8.2 ± 1.5\
mmol/mol 64 ± 10 64 ± 10 66 ± 16

Data are mean ± SD or median (interquartile range) unless otherwise
indicated. FBG, fasting blood glucose.

\*Missing GAD antibody levels for one subject in the sitagliptin group
and two subjects in the placebo group.

†Median time of follow-up after randomization and insulin
discontinuation.:::: At presentation of DKA and severe hyperglycemia, there were no differences in age and BMI among the metformin, sitagliptin, or placebo groups ([Table 1](#)). Although not statistically significant, both the sitagliptin and metformin groups had more men than women, whereas the placebo group had similar proportions of men and women. In the proportion of subjects with DKA or severe hyperglycemia, length and dose of insulin use before randomization (time to near-normoglycemia remission) did not differ between groups. At randomization, there were no significant changes in weight or differences in fasting glucose or HbA~1c~ levels. At the end of the study, there was a significant difference in HbA~1c~ (*P* = 0.04) between the groups ([Table 1](#)). In the patients who remained in near-normoglycemia remission, there was a significant difference in fasting glucose at the end of the study ([Table 1](#)). There were no differences at diagnosis of diabetes in the subjects who remained in near-normoglycemia remission compared with those with hyperglycemia relapse at presentation ([Table 2](#)). At randomization, fasting glucose levels were higher in subjects who experienced hyperglycemia relapse than in those who remained in remission ([Table 2](#)). At the end of the study, fasting glucose and HbA~1c~ levels were higher in the subjects who experienced hyperglycemia relapse ([Table 2](#)). ::::table-wrap
::: caption
Clinical characteristics of obese African American patients with DKA and
severe hyperglycemia with near-normoglycemia remission compared with
those with hyperglycemia relapse
:::

```
                                           Near-normoglycemia remission (*n* = 28)   Hyperglycemia relapse (*n* = 20)   *P* value
```

______________________________________________________________________

Sex (*n*) 0.38
Male 19 11\
Female 9 9\
Age (years) 48 ± 10 49 ± 12 0.73
At diagnosis of diabetes\
BMI (kg/m^2^) 35.2 ± 5.0 36.6 ± 9.0 0.96
DKA/severe hyperglycemia (*n*) 15/13 7/13 0.24
Family history of type 2 diabetes (%) 82 90 0.68
FBG 0.95
mmol/L 42.5 ± 16 41.4 ± 13.2\
mg/dL 765 ± 288 745 ± 239\
GAD antibody positivity[†](#) \[*n* (%)\] 2 (7) 3 (17) 0.64
HbA~1c~ 0.75
% 13.2 ± 2.2 13.0 ± 2.2\
mmol/mol 121 ± 24 119 ± 24\
Fasting C-peptide (pg/L) 3.3 ± 1.1 2.8 ± 1.3 0.25
At randomization\
FBG 0.007
mmol/L 6.1 ± 0.9 7.0 ± 1.1\
mg/dL 110 ± 17 126 ± 20\
HbA~1c~ 0.14
% 6.3 ± 0.8 6.7 ± 0.5\
mmol/mol 49 ± 12 60 ± 16\
Insulin dose (units/kg/day) 0.6 ± 0.2 0.7 ± 0.4 0.67
Length of insulin use (weeks) 8.6 ± 3.1 9.1 ± 2.9 0.57
ΔWeight from enrollment (kg) −0.4 (−6.9, 1.8) 0.8 (−5.4, 4.5) 0.24
At end of study\
ΔWeight from randomization (kg) −0.4 (−2.5, 3.1) 2.1 (−0.4, 5.6) 0.11
FBG \<0.0001
mmol/L 6.3 ± 0.9 8.7 ± 2.8\
mg/dL 114 ± 17 156 ± 50\
HbA~1c~ \<0.0001
% 6.0 ± 0.7 8.1 ± 1.2\
mmol/mol 42 ± 8 65 ± 13

Data are mean ± SD or median (interquartile range) unless otherwise
indicated. FBG, fasting blood glucose.

†Missing GAD antibody levels for one subject in the near-normoglycemia
remission group and two subjects in the hyperglycemia relapse group.:::: Hyperglycemia relapse-free survival was significantly higher in the metformin and sitagliptin groups than in the placebo group (*P* = 0.015) ([Fig. 1](#)). The 2-year failure rate was higher in the placebo than in the sitagliptin (77% vs. 44%, *P* = 0.113) or metformin (77% vs. 34%, *P* = 0.013) groups. Compared with placebo, patients randomized to metformin (hazard ratio 0.28 [95% CI 0.10--0.814]) and sitagliptin (0.31 [0.10--0.98]) were ∼70% less likely to have a hyperglycemia relapse. However, there was no difference in hyperglycemia relapse-free survival between metformin and sitagliptin (*P* = 0.75) ([Fig. 1](#)). The restricted mean time to hyperglycemia relapse in the combined metformin and sitagliptin groups was significantly higher than placebo (480 vs. 305 days, *P* = 0.004). <figure> <p><img src="" /></p> <figcaption>Cox proportional hazards of failure-free survival among metformin, sitagliptin, and placebo in obese African American patients presenting with DKA and severe hyperglycemia. A significant difference was found among the placebo, metformin, and sitagliptin groups (<em>P</em> = 0.015), but no significant difference was found between the sitagliptin and metformin groups (<em>P</em> = 0.75).</figcaption> </figure> We also assessed whether being on medication decreased the severity of hyperglycemia relapse. Because only a small number of subjects experienced relapse in the medication groups (metformin \[*n* = 5\], sitagliptin \[*n* = 4\]) compared with placebo (*n* = 11), we combined the metformin and sitagliptin groups. There were no significant differences in HbA~1c~ (8.0 ± 0.8% [64 ± 9 mmol/mol] vs. 8.2 ± 1.5% [66 ± 16 mmol/mol], *P* = 0.79) or blood glucose (152 ± 18 mg/dL [8.4 ± 1 mmol/L] vs. 160 ± 68 mg/dL [8.9 ± 3.8 mmol/L], *P* = 0.65) levels at the time of hyperglycemia relapse between the placebo group and the combined metformin and sitagliptin group. In the placebo group, 3 of the 11 subjects who experienced hyperglycemia relapse presented to the emergency department with a glucose level >400 mg/dL (22.2 mmol/mol) or DKA. None of the patients in the metformin and sitagliptin group had a hyperglycemia relapse necessitating a visit to the emergency department or admission to the hospital. The difference in hyperglycemia relapse was explained by improvements in β-cell function. Over the course of the study, DI (*P* = 0.02) and incremental AUCi (*P* < 0.001) were significantly higher in subjects who remained in near-normoglycemia remission compared with those who had a hyperglycemia relapse without any differences in Si (*P* = 0.75). There was a significant interaction between remission status and study visit for both Si (*P* = 0.01) and DI (*P* = 0.02), suggesting a different pattern of change in Si and DI over time between subjects with near-normoglycemia remission and hyperglycemia relapse. The difference in DI and incremental AUCi was not present at randomization in the subjects who stayed in near-normoglycemia remission compared with those who experienced a hyperglycemia relapse ([Fig. 2*A* and *B*](#)). At the last documented follow-up, there were no differences in Si ([Fig. 2*C*](#)); however, DI (*P* = 0.02) and incremental AUCi (*P* < 0.001) were significantly higher in subjects who stayed in near-normoglycemia remission than in those who had a hyperglycemia relapse at the end of the study ([Fig. 2*A* and *B*](#)). Comparison across treatment groups showed no differences at randomization, over the course of the study, or at the last follow-up for DI, incremental AUCi, or Si (data not shown). Similarly, a comparison of subjects with an initial presentation of DKA and severe hyperglycemia showed no differences in Si, incremental AUCi, or DI at randomization, over the course of the study, or at the last follow-up (data not shown). Although there were no significant changes in weight, we performed analyses adjusting for changes in weight throughout the course of the study. No differences were found in Si, incremental AUCi, or DI compared with unadjusted analyses. <figure> <p><img src="" /></p> <figcaption>DI, incremental AUCi, and Si at randomization and last follow-up. At randomization OGTT, no significant differences were found in DI, incremental AUCi, or Si in subjects who remained in near-normoglycemia remission at the end of the study compared with those with hyperglycemia relapse. During the last follow-up OGTT, subjects who remained in remission had higher DI and incremental AUCi than those who had a relapse (<em>ABackgroundMiddle-aged women are at risk of weight gain and associated comorbidities. Deliberate restriction of food intake (dieting) produces short-term weight loss but is largely unsuccessful for long-term weight management. Two promising approaches for the prevention of weight gain are intuitive eating (ie, eating in accordance with hunger and satiety signals) and the development of greater psychological flexibility (ie, the aim of acceptance and commitment therapy [ACT]).ObjectivesThis pilot study investigated the usage, acceptability, and feasibility of “Mind, Body, Food,” a Web-based weight gain prevention intervention prototype that teaches intuitive eating and psychological flexibility skills.MethodsParticipants were 40 overweight women (mean age 44.8 [standard deviation, SD, 3.06] years, mean body mass index [BMI] 32.9 [SD 6.01] kg/m<sup>2</sup>, mean Intuitive Eating Scale [IES-1] total score 53.4 [SD 7.46], classified as below average) who were recruited from the general population in Dunedin, New Zealand. Module completion and study site metrics were assessed using Google Analytics. Use of an online self-monitoring tool was determined by entries saved to a secure online database. Intervention acceptability was assessed postintervention. BMI, intuitive eating, binge eating, psychological flexibility, and general mental and physical health were assessed pre- and postintervention and 3-months postintervention.ResultsOf the 40 women enrolled in the study, 12 (30%) completed all 12 modules (median 7.5 [interquartile range, IQR, 2-12] modules) and 4 (10%) used the self-monitoring tool for all 14 weeks of the intervention period (median 3 [IQR 1-9] weeks). Among 26 women who completed postintervention assessments, most women rated “Mind, Body, Food” as useful (20/26, 77%), easy to use (17/25, 68%) and liked the intervention (22/25, 88%). From pre- to postintervention, there were statistically significant within-group increases in intuitive eating (IES-2 total score <em>P</em>\<.001; all IES-2 subscale scores: <em>P</em> ≤.01), psychological flexibility (<em>P</em>=.01), and general mental health (<em>P</em>\<.001) as well as significant decreases in binge eating (<em>P</em>=.01). At the 3-month follow-up, IES-2 improvements were maintained, and there were further improvements in binge eating (<em>P</em>\<.001) and general mental health (<em>P</em>=.03), and a marginal yet nonsignificant tendency for further improvement in psychological flexibility (<em>P</em>=.06). There were no significant within-group changes in BMI from pre- to postintervention and postintervention to 3-month follow-up (<em>P</em>=.46 and <em>P</em>=.93, respectively).ConclusionsThe “Mind, Body, Food” prototype Web-based intervention is appealing to middle-aged women and may be a useful tool to help women learn intuitive eating and ACT skills, reduce binge eating, and maintain weight over 3 months. Further work to improve the user experience and engagement is required before testing the online intervention in a randomized controlled trial.ResultsRecruitment and RetentionDuring recruitment, of the 97 women who expressed interest in the study, 75 women met preliminary screening criteria and subsequently were invited to complete the online eligibility assessment. Five women did not complete the online eligibility assessment, and only 45 women met the study inclusion criteria (see <a href="#">Figure 6</a> for reasons women were excluded). A total of 40 women were enrolled in the study from August to September 2014. The postintervention retention rate was 65% (26/40) and 63% (25/40) at the 3-month follow-up. Although the attrition rate was similar to that predicted (30%), the sample size at follow-up was lower than had been aimed for due to the number of women not meeting eligibility criteria. <a href="#">Figure 6</a> presents the flow of participants through the study.Figure 6"Mind, Body, Food" study participant flow diagram.Baseline Characteristics<a href="#">Table 2</a> presents the sample’s demographic characteristics at baseline in comparison with corresponding NZ Census data. The sample was overrepresentative of NZ European women (30/37, 81.1% vs 69.8%) but similarly representative of Māori (4/37, 10.8% vs 11.7%) and Pacific (1/37, 2.7% vs 4.4%) women. University-educated women were overrepresented (21/37, 56.8% vs 17.7%). Women with NZSEI-06 (estimating socioeconomic status) scores in the lower two quartiles were underrepresented (10-33: 2/37, 5.4% vs 23.1%, 34-44: 3/37, 8.1% vs 29.4%). Half (18/36, 50.0%) of women reported dieting for 20 years or longer. There were no statistically significant differences in demographic characteristics or other measures such as intuitive eating, binge eating, general mental health, psychological inflexibility, and BMI between women who were retained and not retained at 3-month follow-up. Table 2Baseline characteristics of “Mind, Body, Food” participants (n=40).CharacteristicAll participantsNational data Age, years, mean44.8—IES-1<sup>a</sup> summed total score \[<a href="#">17</a>\], mean53.469.4<strong>Ethnicity \[<a href="#">54</a>\], %<sup>b</sup></strong><br /> New Zealand European81.169.8<br /> Māori10.811.7<br /> Pacific2.74.4<br /> Other5.44.6<strong>Highest level of education attained \[<a href="#">54</a>\], %<sup>b</sup></strong><br /> Secondary school or less16.259.1<br /> Technical/trade school or polytechnic27.023.2<br /> University56.817.7<strong>Employment \[<a href="#">55</a>\], %<sup>b</sup></strong><br /> Employed89.281.2-81.8<br /> Employed full time59.5—<br /> Employed part time29.7—<br /> Homemaker5.4—<br /> Other5.4—<strong>Socioeconomic status (NZSEI-06)<sup>c</sup> \[<a href="#">56</a>\], %<sup>b</sup></strong><br /> 62-90 (higher socioeconomic status)48.626.0<br /> 45-6137.821.5<br /> 34-448.129.4<br /> 10-33 (lower socioeconomic status)5.423.1BMI<sup>d</sup> (kg/m<sup>2</sup>) \[<a href="#">57</a>\], mean32.9227.8<strong>IES-2<sup>e</sup> total, mean</strong>2.53—<br /> UPE<sup>f</sup>, mean3.06—<br /> EPR<sup>g</sup>, mean2.17—<br /> RHS<sup>h</sup>, mean2.33—<br /> B-FCC<sup>i</sup>, mean2.85—AAQ-II<sup>j</sup>, mean22.01—PCS<sup>k</sup>, mean50.01—MCS<sup>l</sup>, mean46.32—<strong>Binge eating, %<sup>m</sup></strong><br /> Yes46.2—<br /> No53.8—<strong>Dieting history, %<sup>n</sup></strong><br /> 0-4 years27.8—<br /> 5-19 years22.2—<br /> 20+ years50.0—<a href="#fn1" class="footnote-ref" id="fnref1" role="doc-noteref"><sup>1</sup></a><a href="#fn2" class="footnote-ref" id="fnref2" role="doc-noteref"><sup>2</sup></a><a href="#fn3" class="footnote-ref" id="fnref3" role="doc-noteref"><sup>3</sup></a><a href="#fn4" class="footnote-ref" id="fnref4" role="doc-noteref"><sup>4</sup></a><a href="#fn5" class="footnote-ref" id="fnref5" role="doc-noteref"><sup>5</sup></a><a href="#fn6" class="footnote-ref" id="fnref6" role="doc-noteref"><sup>6</sup></a><a href="#fn7" class="footnote-ref" id="fnref7" role="doc-noteref"><sup>7</sup></a><a href="#fn8" class="footnote-ref" id="fnref8" role="doc-noteref"><sup>8</sup></a><a href="#fn9" class="footnote-ref" id="fnref9" role="doc-noteref"><sup>9</sup></a><a href="#fn10" class="footnote-ref" id="fnref10" role="doc-noteref"><sup>10</sup></a><a href="#fn11" class="footnote-ref" id="fnref11" role="doc-noteref"><sup>11</sup></a><a href="#fn12" class="footnote-ref" id="fnref12" role="doc-noteref"><sup>12</sup></a><a href="#fn13" class="footnote-ref" id="fnref13" role="doc-noteref"><sup>13</sup></a><a href="#fn14" class="footnote-ref" id="fnref14" role="doc-noteref"><sup>14</sup></a>Usage During the 14-week InterventionGoogle Analytics recorded “Mind, Body, Food” online traffic for 37 participants for 92 days at the end of the 14-week trial. A programming delay prevented monitoring from the start of the study, which explains missing usage data for three women. Of the 37 participants for whom usage data were available, 12 (32%) completed all 12 modules, 11 (30%) completed 7 to 11 modules, 12 (32%) completed 1 to 6 modules, and two women (5%) completed no modules. The median number of modules completed was 7.5 (interquartile range [IQR] 2-12) modules. The median number of sessions during the monitored period was 7 (a minimum of 1 session to a maximum of 66 sessions). The median session duration during the monitored period was 12 minutes, 54 seconds (a minimum of 3 minutes, 58 seconds, to a maximum of 100 minutes, 8 seconds). The median number of EAT entries over the 14-week intervention was 7 (a minimum of 1 entry to a maximum of 314 entries). The median number of weeks that participants recorded eating experiences in the EAT was 3 (IQR 1-9) weeks. Of the 40 participants enrolled in the study, 4 women (10%) used the EAT for at least 12 weeks of their intervention period, 7 (18%) used the EAT for 7 to 11 weeks, 20 (50%) used the EAT for 1 to 6 weeks, and 9 (23%) did not use the EAT during their intervention period.Eleven women had limited access to “Mind, Body, Food” for more than 5 days, predominantly due to being away from home (n=8) or technical issues (n=3). Technical issues that prevented module completion included attempting to access “Mind, Body, Food” from an incompatible browser (n=3), using incorrect login details (n=1), and other issues not described (n=1). Seven women reported appetite being affected for more than 5 days (eg, due to illness) during the 14-week intervention.AcceptabilityA total of 26 women completed acceptability measures, and of these 12 had completed all modules, 10 completed 7 to 11 modules, and 4 completed 2 to 6 modules. <a href="#">Table 3</a> shows that participants’ overall impression of “Mind, Body, Food” was positive. Most participants liked “Mind, Body, Food” and found the intervention useful (20/26, 77%), easy to use (17/25, 68%), easy to understand (23/25, 92%), and would recommend the program to others (21/25, 84%). Nearly half (12/25, 48%) of participants reported that “Mind, Body, Food” made it easy to learn intuitive eating skills.Of all module components, the videos were more frequently rated as being quite or extremely useful by participants compared to the audio and typed activities (<a href="#">Table 3</a>). Five out of 24 women (21%) women rated the EAT self-monitoring tool as quite or extremely useful, 3 out of 19 women (16%) found email reminders to use the EAT useful, and 4 out of 12 women (33%) found SMS reminders to use the EAT useful (not shown). In regards to reminders sent to begin the next module, 17 out of 26 women (68%) rated the email reminders as quite or extremely useful. Of the women (9/24, 38%) who chose to receive SMS reminders to begin the next module, 6 (67%) rated the reminders as useful (not shown).Of the 20 women who currently owned a smartphone, 16 (80%) reported that if it were available a mobile version of “Mind, Body, Food” would be quite or extremely useful to them.Table 3User experiences of “Mind, Body, Food” (n=26).Acceptability measuresn (%)Median<strong>Overall impression</strong><br /> <strong>Overall, to what extent did you like “Mind, Body, Food?”</strong>4<br /> <br /> Disliked very much0 (0)<br /> <br /> <br /> Disliked somewhat0 (0)<br /> <br /> <br /> Neither liked nor disliked3 (12)<br /> <br /> <br /> Liked somewhat10 (40)<br /> <br /> <br /> Liked very much12 (48)<br /> <br /> <br /> Missing1<br /> <br /> <strong>Overall, to what extent was “Mind, Body, Food” useful to you?</strong>4<br /> <br /> Not useful0 (0)<br /> <br /> <br /> A little useful2 (8)<br /> <br /> <br /> Somewhat useful4 (15)<br /> <br /> <br /> Quite useful9 (35)<br /> <br /> <br /> Extremely useful11 (42)<br /> <br /> <strong>Overall, to what extent did you find “Mind, Body, Food” easy to use?</strong>4<br /> <br /> Not at all easy0 (0)<br /> <br /> <br /> Not very easy3 (12)<br /> <br /> <br /> Somewhat easy5 (20)<br /> <br /> <br /> Very easy12 (48)<br /> <br /> <br /> Extremely easy5 (20)<br /> <br /> <br /> Missing1<br /> <br /> <strong>Overall, to what extent did you find “Mind, Body, Food” content easy to understand?</strong>4<br /> <br /> Not at all easy0 (0)<br /> <br /> <br /> Not very easy0 (0)<br /> <br /> <br /> Somewhat easy2 (8)<br /> <br /> <br /> Very easy15 (60)<br /> <br /> <br /> Extremely easy8 (32)<br /> <br /> <br /> Missing1<br /> <br /> <strong>Overall, to what extent did “Mind, Body, Food” make it easy for you to learn intuitive eating skills?</strong>3<br /> <br /> Not at all easy0 (0)<br /> <br /> <br /> Not very easy2 (8)<br /> <br /> <br /> Somewhat easy11 (44)<br /> <br /> <br /> Very easy9 (36)<br /> <br /> <br /> Extremely easy3 (12)<br /> <br /> <br /> Missing1<br /> <br /> <strong>Would you recommend “Mind, Body, Food” to others?</strong>5<br /> <br /> No, definitely wouldn’t0 (0)<br /> <br /> <br /> No, probably wouldn’t0 (0)<br /> <br /> <br /> Unsure4 (16)<br /> <br /> <br /> Yes, probably would8 (32)<br /> <br /> <br /> Yes, definitely would13 (52)<br /> <br /> <br /> Missing1<br /> <strong>Usefulness of program features</strong><br /> <strong>How useful did you find the videos?</strong>4<br /> <br /> Not useful0 (0)<br /> <br /> <br /> A little useful4 (16)<br /> <br /> <br /> Somewhat useful4 (16)<br /> <br /> <br /> Quite useful7 (28)<br /> <br /> <br /> Extremely useful10 (40)<br /> <br /> <br /> Missing1<br /> <br /> <strong>How useful did you find the audio activities?</strong>3<br /> <br /> Not useful4 (16)<br /> <br /> <br /> A little useful5 (20)<br /> <br /> <br /> Somewhat useful7 (28)<br /> <br /> <br /> Quite useful7 (28)<br /> <br /> <br /> Extremely useful2 (8)<br /> <br /> <br /> Missing1<br /> <br /> <strong>How useful did you find the typed activities?</strong>3<br /> <br /> Not useful4 (16)<br /> <br /> <br /> A little useful3 (12)<br /> <br /> <br /> Somewhat useful11 (44)<br /> <br /> <br /> Quite useful4 (16)<br /> <br /> <br /> Extremely useful3 (12)<br /> <br /> <br /> Missing1<br /> <br /> <strong>How useful did you find the E.A.T.?</strong>2<br /> <br /> Not useful5 (21)<br /> <br /> <br /> A little useful9 (38)<br /> <br /> <br /> Somewhat useful5 (21)<br /> <br /> <br /> Quite useful3 (13)<br /> <br /> <br /> Extremely useful2 (8)<br /> <br /> <br /> Missing2<br /> <br /> <strong>How useful did you find the email reminders to begin the next module?</strong>3<br /> <br /> Not useful2 (8)<br /> <br /> <br /> A little useful1 (4)<br /> <br /> <br /> Somewhat useful5 (20)<br /> <br /> <br /> Quite useful9 (36)<br /> <br /> <br /> Extremely useful8 (32)<br /> <br /> <br /> Missing1<br /> Changes in Eating BehaviorThe study was not designed to detect the effects of the intervention on the outcome measures (no control group was included), but within-group comparisons were performed as part of the feasibility component of the pilot study. From pre- to postintervention, there were statistically significant increases in IES-2 total scores and all four IES-2 subscale scores (<a href="#">Table 4</a>). There was no evidence that these improvements diminished at the 3-month follow-up. Based on use of the dichotomous variable (ie, binge eating vs no binge eating), 7 out of 14 women who reported eating a significantly large amount of food (ie, binge eating) at the preintervention assessment reported no binge eating at the postintervention assessment. There were no women who transitioned from no binge eating at the preintervention assessment to binge eating at the postintervention assessment or at the 3-month follow-up; 4 women who reported binge eating at postintervention no longer reported binge eating at the 3-month follow-up. McNemar’s test revealed a significant decrease in the proportion of women binge eating from the pre- to postintervention visits (<em>P</em>=.01) and a significant decrease from postintervention to follow-up (<em>P</em>\<.001). The median days women who were categorized as binge eaters reported binge eating at preintervention was 4.25 (IQR 2.5-10) days, at postintervention was 4 (IQR 2-8) days, and at the 3-month follow-up it was 2 (IQR 2-4) days. A Wilcoxon matched-pairs signed-rank test was used to examine changes in the reported number of days women were unable to prevent or stop episodes of eating an unusually large amount of food and revealed a significant decrease from pre- to postintervention (<em>P</em>=.03) and no evidence of a change from postintervention to follow-up (<em>P</em>=.57).Psychological Inflexibility, Quality of Life, and BMIPsychological inflexibility decreased significantly from pre- to postintervention (mean change −4.23 [SD 7.13], <em>P</em>=.006), and there was a tendency for a further decrease in psychological inflexibility from postintervention to 3-month-follow-up (mean change −2.60 [SD 6.58], <em>P</em>=.06) (<a href="#">Table 4</a>). There were no significant changes in general physical health from pre- to postintervention (pre- to postintervention PCS scores: mean change 0.29 [SD 9.35], <em>P</em>=.88; postintervention to 3-month follow-up PCS scores: mean change 1.26 [SD 10.46], <em>P</em>=.55). However, general mental health improved significantly from pre- to postintervention with a further improvement postintervention to 3-month follow-up (mean change 5.07 [SD 6.31], <em>P</em>\<.001; mean change 3.45 [SD 7.71], <em>P</em>=.03, respectively). There were no statistically significant changes in BMI from pre- to postintervention or postintervention to 3-month follow-up (mean change −0.13 [SD 0.88], <em>P</em>=.46 and mean change −0.01 [SD 0.57], <em>P</em>=.93, respectively).Associations Between Changes in Intuitive Eating With BMI and Psychological InflexibilitySpearman correlations showed a statistically significant inverse relationship between pre- to postintervention change in total intuitive eating scores and pre- to postintervention change in BMI (<em>r</em><sub>s</sub>=−.43, <em>P</em>=.03). Thus, greater decreases in BMI were associated with greater increases in intuitive eating. However, when relationships with individual subscales were examined, a significant association was found for only one subscale: greater decreases in BMI were associated with greater increases in eating for physical rather than emotional reasons (<em>r</em><sub>s</sub>=−.56, <em>P</em>=.003). There was also a statistically significant inverse relationship between change in psychological inflexibility scores and change in intuitive eating scores (<em>r</em><sub>s</sub>=−.52, <em>P</em>=.006); that is, greater improvements in psychological flexibility were associated with greater increases in total intuitive eating scores. Furthermore, larger improvements in psychological flexibility were associated with greater increases in two subscale scores: eating for physical rather than emotional reasons (<em>r</em><sub>s</sub>=−.41, <em>P</em>=.04) and reliance on hunger and satiety cues (<em>r</em><sub>s</sub>=−.62, <em>P</em>\<.001). A greater reduction in psychological inflexibility scores was also associated with a greater decrease in BMI (<em>r</em>=.41, <em>P</em>=.04).Table 4Changes from pre- (n=26) to postintervention (n=26) and from postintervention to 3-month follow-up (n=25).CharacteristicMean (SD)Change (SD)<sup>a</sup>95% CI<em>P</em> value<sup>b</sup>IES-2<sup>c</sup> total<br /> Preintervention2.54 (0.58)———<br /> Postintervention3.45 (.55)0.94 (0.67)0.67, 1.21\<.001<br /> 3-month follow-up3.53 (.61)0.08 (0.55)−0.15, 0.31.47UPE<sup>d</sup><br /> Preintervention3.07 (0.73)———<br /> Postintervention3.56 (.54)0.52 (0.87)0.17, 0.87.01<br /> 3-month follow-up3.47 (.58)−0.09 (0.64)−0.36, 0.17.76EPR<sup>e</sup><br /> Preintervention2.19 (0.96)———<br /> Postintervention3.21 (.89)1.08 (0.96)0.69, 1.46\<.001<br /> 3-month follow-up3.49 (.88)0.28 (0.89)−0.09, 0.65.13RHS<sup>f</sup><br /> Preintervention2.33 (0.77)———<br /> Postintervention3.58 (.76)1.28 (0.98)0.89, 1.68\<.001<br /> 3-month follow-up3.55 (.81)−0.03 (0.68)−0.31, 0.25.81B-FCC<sup>g</sup><br /> Preintervention2.87 (0.61)———<br /> Postintervention3.59 (.81)0.74 (0.61)0.50, 1.00\<.001<br /> 3-month follow-up3.72 (.72)0.13 (0.87)−0.23, 0.49.45BMI<sup>h</sup> (kg/m<sup>2</sup>)<br /> Preintervention32.93 (4.85)———<br /> Postintervention32.81 (5.31)−0.13 (0.88)−0.48, 0.23.46<br /> 3-month follow-up<sup>i</sup>32.80 (5.29)−0.01 (0.57)−0.28, 0.26.93AAQ-II<sup>j</sup><br /> Preintervention22.46 (8.67)———<br /> Postintervention18.23 (8.14)−4.23 (7.13)−7.11, -1.35.006<br /> 3-month follow-up16.08 (7.73)−2.60 (6.58)−5.32, 0.16.06SF-12v2 PCS<sup>k</sup><br /> Preintervention50.46 (7.83)———<br /> Postintervention50.87 (11.02)0.29 (9.35)−3.49, 4.06.88<br /> 3-month follow-up52.13 (6.78)1.26 (10.46)−3.06, 5.58.55SF-12v2 MCS<sup>l</sup><br /> Preintervention45.63 (6.31)———<br /> Postintervention50.24 (7.41)5.07 (6.31)2.52, 7.61\<.001<br /> 3-month follow-up53.70 (4.99)3.45 (7.71)0.27, 6.63.03<a href="#fn15" class="footnote-ref" id="fnref15" role="doc-noteref"><sup>15</sup></a><a href="#fn16" class="footnote-ref" id="fnref16" role="doc-noteref"><sup>16</sup></a><a href="#fn17" class="footnote-ref" id="fnref17" role="doc-noteref"><sup>17</sup></a><a href="#fn18" class="footnote-ref" id="fnref18" role="doc-noteref"><sup>18</sup></a><a href="#fn19" class="footnote-ref" id="fnref19" role="doc-noteref"><sup>19</sup></a><a href="#fn20" class="footnote-ref" id="fnref20" role="doc-noteref"><sup>20</sup></a><a href="#fn21" class="footnote-ref" id="fnref21" role="doc-noteref"><sup>21</sup></a><a href="#fn22" class="footnote-ref" id="fnref22" role="doc-noteref"><sup>22</sup></a><a href="#fn23" class="footnote-ref" id="fnref23" role="doc-noteref"><sup>23</sup></a><a href="#fn24" class="footnote-ref" id="fnref24" role="doc-noteref"><sup>24</sup></a><a href="#fn25" class="footnote-ref" id="fnref25" role="doc-noteref"><sup>25</sup></a><a href="#fn26" class="footnote-ref" id="fnref26" role="doc-noteref"><sup>26</sup></a>alic> and <em>B</em>) without a difference in Si (<em>C</em>).</em></figcaption> </figure> <section id="footnotes" class="footnotes footnotes-end-of-document" role="doc-endnotes"> <hr /> <ol> <li id="fn1"><p><sup>a</sup>IES-1: Intuitive Eating Scale-1 (summed scores have potential range 21-105).<a href="#fnref1" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn2"><p><sup>b</sup>Missing data, n=3.<a href="#fnref2" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn3"><p><sup>c</sup>New Zealand Socioeconomic Index.<a href="#fnref3" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn4"><p><sup>d</sup>BMI: body mass index.<a href="#fnref4" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn5"><p><sup>e</sup>IES-2: Intuitive Eating Scale-2 (mean scores have potential range 1-5).<a href="#fnref5" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn6"><p><sup>f</sup>UPE: Unconditional Permission to Eat subscale.<a href="#fnref6" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn7"><p><sup>g</sup>EPR: Eating for Physical Rather than Emotional Reasons subscale.<a href="#fnref7" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn8"><p><sup>h</sup>RHS: Reliance on Internal Hunger and Satiety cues.<a href="#fnref8" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn9"><p><sup>i</sup>B-FCC: Body-Food Choice Congruence.<a href="#fnref9" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn10"><p><sup>j</sup>AAQ-II: Acceptance and Action Questionnaire-II.<a href="#fnref10" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn11"><p><sup>k</sup>PCS: Short Form 12-item (version 2) Health Survey Physical Component Summary.<a href="#fnref11" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn12"><p><sup>l</sup>MCS: Short Form 12-item (version 2) Health Survey Mental Component Summary.<a href="#fnref12" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn13"><p><sup>m</sup>Missing data, n=1.<a href="#fnref13" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn14"><p><sup>n</sup>Missing data, n=4.<a href="#fnref14" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn15"><p><sup>a</sup>Changes from pre- to postintervention and postintervention to 3-month follow-up.<a href="#fnref15" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn16"><p><sup>b</sup>Paired <em>t</em> tests were used to compare IES-2 scores, BMI, AAQ-II scores, and SF-12v2 scores.<a href="#fnref16" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn17"><p><sup>c</sup>IES-2: Intuitive Eating Scale-2.<a href="#fnref17" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn18"><p><sup>d</sup>UPE: Unconditional Permission to Eat subscale.<a href="#fnref18" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn19"><p><sup>e</sup>EPR: Eating for Physical Rather than Emotional Reasons subscale.<a href="#fnref19" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn20"><p><sup>f</sup>RHS: Reliance on Internal Hunger and Satiety cues.<a href="#fnref20" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn21"><p><sup>g</sup>B-FCC: Body-Food Choice Congruence.<a href="#fnref21" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn22"><p><sup>h</sup>BMI: body mass index.<a href="#fnref22" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn23"><p><sup>i</sup>BMI change from postintervention to 3-month follow-up (n=20).<a href="#fnref23" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn24"><p><sup>j</sup>AAQ-II: Acceptance and Action Questionnaire-II.<a href="#fnref24" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn25"><p><sup>k</sup>PCS: Short Form 12-item (version 2) Health Survey Physical Component Summary.<a href="#fnref25" class="footnote-back" role="doc-backlink">↩︎</a></p></li> <li id="fn26"><p><sup>l</sup>MCS: Short Form 12-item (version 2) Health Survey Mental Component Summary.<a href="#fnref26" class="footnote-back" role="doc-backlink">↩︎</a></p></li> </ol> </section>


Extracted trial result:
Outcome: Psychological flexibility (continuous)
Intervention: Intuitive Eating and Acceptance and Commitment Therapy
Comparator: Control
Intervention group size: 26
Intervention mean: 18.23
Intervention standard deviation: 8.14
Comparator group size: 26
Comparator mean: 22.46
Comparator standard deviation: 8.67
Notes: Actually psychological inflexibility in the article