Everyone has a weakness. For Robin Donnelly, it was Peeps.
But Donnelly’s weight problem was about more than the occasional craving for marshmallow candy. She never felt full at meals, and rare was the internal signal to stop eating.
“I didn’t usually eat horribly, I just ate a lot,” she says.
Doctors hope a stomach procedure in clinical trials here and across the country will prove to be a new weight-loss tool for Donnelly and others — people who aren’t dangerously obese but need to lose 30 to 50 pounds.
That, in fact, describes tens of millions of people in the United States. And for the vast majority of them, diet and exercise programs haven’t worked long-term.
The suturing procedure, which requires no incision, makes small, permanent changes to the stomach. There’s evidence the alterations help people lose weight and maintain that loss by ramping up the “full” signal sent to the brain — during and after meals.
The technique would not replace gastric bypass and other types of bariatric surgeries for the morbidly obese. The POSE (Primary Obesity Surgery Endoluminol) procedure is intended for those with body mass indexes (BMI) between 30 and 40.
Donnelly, 46, has been overweight for years, and she has never been OK with it.
“I feel young, I feel healthy, I feel energetic,” she says. “I want the outside to reflect the inside.”
Sreeni Jonnalagadda, chief of gastroenterology at St. Luke’s Hospital, says a small part of the stomach is folded and permanently sutured, limiting the stomach’s ability to stretch during meals. This is performed through a “transport tube” that’s inserted in the mouth, down the esophagus and into the stomach.
Study participants stayed at the hospital overnight, but in practice most patients would go home the same day, requiring few days away from work.
That’s a plus for many who don’t necessarily want to alert others that they’re undergoing a weight-loss procedure.
“It’s your business,” Jonnalagadda says. “Nobody else needs to know.”
The study will follow 330 patients nationwide, and initial results will be ready in about a year.
The St. Luke’s study site has 27 participants. Eighteen received the POSE procedure, and nine received a sham procedure as a control group. Those in the control group are receiving the same follow-up diet and exercise instruction. They will be offered the real procedure at the end of the study.
Donnelly was part of a “lead-in” group that received the procedure.
Jonnalagadda says that about 1,500 POSE procedures have been done in Europe, with typical weight loss of 20 percent of body weight. But those cases were not part of a controlled study. Many people would reap health benefits from losing just 10 percent, he says.
Diet and exercise programs alone haven’t made a dent in the country’s obesity epidemic, says Shelby Sullivan, assistant professor at Washington University School of Medicine. She is leading the St. Louis study site. Only 1 to 2 percent of obese people lose significant weight and keep it off, she said.
“There are very few people who can do it on their own,” Sullivan says. “We need new tools to help people achieve these lifestyle changes.”
The POSE procedure is important because it would be available to those considered obese but who aren’t candidates for gastric bypass surgery, Sullivan says.
Those with a BMI score of 30 to 34.9 who also have high blood pressure, diabetes or high cholesterol would be POSE procedure candidates, as would those with scores from 35 to 40 who don’t have those health factors, she says.
“You feel full earlier in the meal so you stop eating before you consume too many calories, and you feel full longer so you feel less of a need to eat between meals,” Sullivan says.
Study results might be used to seek federal Food and Drug Administration approval for the procedure.
Many factors make it difficult to lose weight, including the easy availability of food, much of it calorie packed, Sullivan says. Every mile of walking burns about 100 calories, she says, but most work and living environments afford us very little daily physical activity.
Other factors: genetics and our “gut microbiome,” the community of microorganisms inside us, Sullivan says. In studies, when the gut microbiomes of obese mice are transferred into lean mice, the lean mice gain weight.
Donnelly had the procedure in March and so far has lost 16 pounds.
“I noticed a difference right away,” Donnelly says. “I ate and I felt full. It was different, odd. I’m relearning meal sizes and portion sizes.”
She said the procedure left her throat sore for a few days, but she had no stomach pain. After the procedure, patients consume a liquid and soft-food diet for six weeks, then are asked to follow long-term eating and exercise guidelines. But their meals aren’t provided, and they aren’t enrolled in a formal exercise program.
Portion size is a vital topic, says Natalie Hayes, a clinical research nurse who is counseling participants. Meat and fish entrees should be about the size of a deck of cards. Drinks should have no added sugar. A typical daily calorie goal is 1,500, she says.
Hayes recommends that people eat at the table and focus on the meal, rather than eating absent-mindedly on the couch.
And they should eat slowly, even putting the fork down between bites, she says. That advice hit home with Donnelly.
“Slowing down is big,” Donnelly says. “You can’t eat in 10 minutes. You have to sit down and take 30 minutes.”
Physical activity is big, too, incorporating chores and hobbies with regular walking and other programs.
The study’s exercise guidelines recommend walking two to three times a day for 10 minutes each time for the first two weeks, increasing to 15 minutes the following two weeks, then aiming for a 30- to 45-minute exercise regimen three times a week.
Donnelly of Kansas City, North, was a dancer in her younger years and is now a coach and judge of competitive all-star cheerleading. She’s also a nurse and a single mom of a 20-year-old daughter and 18-year-old son.
“I don’t feel I fit the ‘fat-girl’ stereotype,” she says. “I’m not sedentary. I’ve been active my whole life. And if right now I’m having my 15 minutes of fame, this is what I want people to know about.”
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SAMPLES OF LOW-CALORIE MEALS
POSE clinical trial participants aren’t provided meals, but a clinical nurse offers eating and exercise recommendations, including examples of meal portions and calorie counts.
1/2 can tuna in water, 1/4 cup (size of half a billiard ball) green beans, 1 tablespoon of olive oil and 11/4 cup (two and a half billiard balls) of pasta.
Chili made with 4 ounces of ground beef, 1 ounce (two dice) of cheddar cheese, 1/4 cup (half a billiard ball) of kidney beans with 1/2 slice of wheat bread.
3 ounces (deck of cards) of pink salmon, 11/4 cups (two and a half billiard balls) of white rice, 1/2 cup (billiard ball) of asparagus made with 2 teaspoons olive oil, 1 medium apple.