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An intensive 1-year behavior therapy program aimed at changing a person’s response to food “cues” might help people with obesity lose a modest amount of weight, a randomized clinical trial suggests.

“Patients who are food-cue sensitive often feel out of control with their eating; they cannot resist food and/or cannot stop thinking about food,” said lead author Kerri N. Boutelle, PhD.

“Behavioral weight loss skills are not sufficient for these individuals,” so they designed this new approach, Boutelle, of the University of California San Diego, La Jolla, cialis super active 20mg explained in a press release.

The regulation of cues (ROC) intervention trains individuals to respond to their hunger and to resist eating highly craved foods (internal management), in contrast to behavioral weight loss programs that focus on counting calories (external management), Boutelle explained in an email to Medscape Medical News.

The results of the Providing Adult Collaborative Interventions for Ideal Changes (PACIFIC) clinical trial, including follow-up out to 2 years, were published May 18 in JAMA Network Open.

Patients in the behavioral weight loss therapy group or the combined ROC and behavioral weight loss therapy group lost more weight at 6 months than patients in the ROC group — but then they slowly regained weight (whereas patients in the ROC group did not).

At 24 months, the three groups had a similar modest weight loss compared with a control group that did not lose weight.

“We believe these internal management strategies are more durable over time,” said Boutelle.  

However, two obesity experts, who helped develop the Canadian Adult Obesity Clinical Practice Guidelines, cautioned in emails to Medscape Medical News that the intervention is very labor-intensive with less than 5% weight loss.

Four Interventions

The trial was conducted at the Center for Healthy Eating and Activity Research at the University of California San Diego from December 2015 to December 2019.

Researchers randomized 271 adults with a mean BMI of 35 kg/m2 to one of four interventions:

  • Regulation of cues: Patients were not given a prescribed diet, but instead were given skills to tolerate cravings and respond better to hunger or satiety cues.

  • Behavioral weight loss therapy: Patients were advised to follow a balanced, calorie-deficit diet based on their weight and given related skills.

  • Combined regulation of cues plus behavioral weight loss therapy.

  • Control: Patients received information about nutrition and stress management plus mindfulness training and were encouraged to find social support.

Therapy was given as 26 group sessions, 90 minutes each, over 12 months, with 16 weekly sessions, four biweekly sessions, and six monthly booster sessions.

Participants were asked to take part in 150 minutes of moderate to high intensity exercise each week and aim for 10,000 steps/day. All patients except those in the control group received a pedometer.

The patients were a mean age of 46 years, 82% were women and 62% were White.

At the end of the 12-month intervention, mean BMI had dropped by –1.18 kg/m2 in the ROC group and by –1.58 kg/m2 and –1.56 kg/m2 in the other two groups, compared with the control group, where BMI was virtually unchanged.

At 24 months follow-up, mean BMI was similar (roughly 33.5 kg/m2) in the ROC, the behavioral weight loss therapy, and the ROC plus behavioral weight loss therapy groups.

There was weight regain from 12 months in the latter two groups but not in the ROC group.

Nice Study, but Not Practical

“This is a nice study, but in no way is it practical,” Sean Wharton, MD, summarized.

“I think it may have difficulty finding its way into everyday practice,” said Wharton, adjunct professor at McMaster University, Hamilton, Ontario, Canada.

Also, “it does not compare ROC to pharmacotherapy,” he added, which is “quickly becoming the gold standard for obesity management. We have learned that adding intensive behavioral therapy — more visits and possibly a liquid diet as part of the weight management and some light group counseling — to pharmacotherapy does not add much.”

However, Wharton conceded that if an individual did not want, or could not take, pharmacotherapy and had access to ROC sessions, this might be a good option.

“The challenge will be offering this labor-intensive tool to 40% of Americans living with obesity,” he said.

The ROC intervention “is very different than a GP’s office that may see a patient two to three times/year max, with limited supports,” Wharton pointed out.

“It is labor-intensive, not reproducible in most places, and cannot be sustained forever. There is no evidence that the learning remains past the treatment interval. For example, 2 to 3 years later, are patients still adhering to ROC? Is weight still decreased or do they need to come to classes every month forever?”  

Modest Weight Loss, Doubtful Long-Term Benefits

Similarly, Arya M. Sharma, MD, said: “While this [ROC] approach may be helpful for some individuals, given the rather modest weight loss achieved (despite considerable efforts and a cash incentive), the long-term clinical benefits remain doubtful.”

The weight loss of less than 5% over 24 months is “in the ballpark of other behavioral weight-loss interventions,” said Sharma, of the University of Edmonton, Alberta, Canada, and past scientific director of Obesity Canada.  

“I’m not convinced” about less weight regain, he added. “The difference between the groups is minimal. While this approach may well help individuals better deal with food cues, it does not change the underlying biology of weight regain.”

“This approach at best may help prevent future weight gain in susceptible individuals,” he speculated. “I would consider this more as a weight-stabilization than a weight-loss strategy.”

Next Steps

Insurance doesn’t always cover weight loss with a mental health professional, Boutelle agreed. “However, there are eating disorder categories that also apply to many of our food-cue-sensitive patients, including binge eating,” she noted.

“We believe that ROC is an alternative model for weight loss that could be offered to patients who are interested or for whom behavioral weight loss has not been successful…who are highly food-cue-responsive.”

The group is writing a manual about the ROC program to disseminate to other behavior therapists. They are also studying ROC in another clinical trial, Solutions for Hunger and Regulating Eating (SHARE). The ROC program is being offered at the UC San Diego Center for Healthy Eating and Activity Research, of which Boutelle is director.

The study was supported by grants from the National Institutes of Health. The researchers have reported no relevant financial relationships. Wharton has reported receiving honoraria and travel expenses and has participated in academic advisory boards for Novo Nordisk, Bausch Health, Eli Lilly, and Janssen. He is the medical director of a medical clinic specializing in weight management and diabetes. Sharma has reported receiving speakers bureau and consulting fees from Novo Nordisk, Bausch Pharmaceuticals, and AstraZeneca.

JAMA Netw Open. Published online May 18, 2022. Full text

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