Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results (2023)

Abstract

An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One hundred eighty-three participants were recruited, with a mean body mass index of 34.75 ± 2.75 kg/m2. General dropout rate at 6 months was 26.8%. Weight changes were statistically significant at months 3 and 6 compared to baseline, -2.915 ± 0.24 kg, -3.29 ± 0.36 kg, respectively (P < 0.001), but not statistically significant between the 3- and 6-month time points -0.37 ± 0.21 kg (P = 0.24). Mean group differences showed that the TI group lost 1.61 ± 1.88 kg more than the NTI group (P = 0.39). Waist, waist/hip ratio, resting heart rate, blood pressure, HbA1c, and low-density lipoprotein cholesterol also showed statistically significant changes at 6 months, with no significant differences between groups. Weight loss in the TI group shows similar results as the usual care NTI group for weight loss and control of obesity comorbidities. At completion of the clinical trial, these results will be reevaluated to assess the potential role of web support in weight-loss maintenance and its cost-effectiveness.

Original languageEnglish
Pages (from-to)380-385
Number of pages6
JournalDiabetes Technology and Therapeutics
Volume20
Issue number5
DOIs
Publication statusPublished - May 2018

Keywords

  • Lifestyle modification.
  • Metabolic syndrome
  • Obesity
  • Telemedicine

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Alcántara-Aragón, V., Rodrigo-Cano, S., Lupianez-Barbero, A., Martinez, M. J., Martinez, C., Tapia, J., Iniesta, J. M., Tenes, S., Urgell, E., Navarro, G., Hernando, M. E., Merino-Torres, J. F., De Leiva, A., & Gonzalez, C. (2018). Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. Diabetes Technology and Therapeutics, 20(5), 380-385. https://doi.org/10.1089/dia.2017.0456

Alcántara-Aragón, Valeria ; Rodrigo-Cano, Susana ; Lupianez-Barbero, Ascension et al. / Web Support for Weight-Loss Interventions : PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. In: Diabetes Technology and Therapeutics. 2018 ; Vol. 20, No. 5. pp. 380-385.

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title = "Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results",

abstract = "An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One hundred eighty-three participants were recruited, with a mean body mass index of 34.75 ± 2.75 kg/m2. General dropout rate at 6 months was 26.8%. Weight changes were statistically significant at months 3 and 6 compared to baseline, -2.915 ± 0.24 kg, -3.29 ± 0.36 kg, respectively (P < 0.001), but not statistically significant between the 3- and 6-month time points -0.37 ± 0.21 kg (P = 0.24). Mean group differences showed that the TI group lost 1.61 ± 1.88 kg more than the NTI group (P = 0.39). Waist, waist/hip ratio, resting heart rate, blood pressure, HbA1c, and low-density lipoprotein cholesterol also showed statistically significant changes at 6 months, with no significant differences between groups. Weight loss in the TI group shows similar results as the usual care NTI group for weight loss and control of obesity comorbidities. At completion of the clinical trial, these results will be reevaluated to assess the potential role of web support in weight-loss maintenance and its cost-effectiveness.",

keywords = "Lifestyle modification., Metabolic syndrome, Obesity, Telemedicine",

author = "Valeria Alc{\'a}ntara-Arag{\'o}n and Susana Rodrigo-Cano and Ascension Lupianez-Barbero and Martinez, {Mar{\'i}a Jos{\'e}} and Carmen Martinez and Jos{\'e} Tapia and Iniesta, {Jos{\'e} Manuel} and Susana Tenes and Eulalia Urgell and Gemma Navarro and Hernando, {M. Elena} and Merino-Torres, {Juan Francisco} and {De Leiva}, Alberto and Cintia Gonzalez",

note = "Publisher Copyright: {\textcopyright} Copyright 2018, Mary Ann Liebert, Inc. 2018.",

year = "2018",

month = may,

doi = "10.1089/dia.2017.0456",

language = "English",

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Alcántara-Aragón, V, Rodrigo-Cano, S, Lupianez-Barbero, A, Martinez, MJ, Martinez, C, Tapia, J, Iniesta, JM, Tenes, S, Urgell, E, Navarro, G, Hernando, ME, Merino-Torres, JF, De Leiva, A & Gonzalez, C 2018, 'Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results', Diabetes Technology and Therapeutics, vol. 20, no. 5, pp. 380-385. https://doi.org/10.1089/dia.2017.0456

Web Support for Weight-Loss Interventions : PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. / Alcántara-Aragón, Valeria; Rodrigo-Cano, Susana; Lupianez-Barbero, Ascension et al.

In: Diabetes Technology and Therapeutics, Vol. 20, No. 5, 05.2018, p. 380-385.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Web Support for Weight-Loss Interventions

T2 - PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results

AU - Alcántara-Aragón, Valeria

AU - Rodrigo-Cano, Susana

AU - Lupianez-Barbero, Ascension

AU - Martinez, María José

AU - Martinez, Carmen

AU - Tapia, José

AU - Iniesta, José Manuel

AU - Tenes, Susana

AU - Urgell, Eulalia

AU - Navarro, Gemma

AU - Hernando, M. Elena

AU - Merino-Torres, Juan Francisco

AU - De Leiva, Alberto

AU - Gonzalez, Cintia

N1 - Publisher Copyright:© Copyright 2018, Mary Ann Liebert, Inc. 2018.

PY - 2018/5

Y1 - 2018/5

N2 - An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One hundred eighty-three participants were recruited, with a mean body mass index of 34.75 ± 2.75 kg/m2. General dropout rate at 6 months was 26.8%. Weight changes were statistically significant at months 3 and 6 compared to baseline, -2.915 ± 0.24 kg, -3.29 ± 0.36 kg, respectively (P < 0.001), but not statistically significant between the 3- and 6-month time points -0.37 ± 0.21 kg (P = 0.24). Mean group differences showed that the TI group lost 1.61 ± 1.88 kg more than the NTI group (P = 0.39). Waist, waist/hip ratio, resting heart rate, blood pressure, HbA1c, and low-density lipoprotein cholesterol also showed statistically significant changes at 6 months, with no significant differences between groups. Weight loss in the TI group shows similar results as the usual care NTI group for weight loss and control of obesity comorbidities. At completion of the clinical trial, these results will be reevaluated to assess the potential role of web support in weight-loss maintenance and its cost-effectiveness.

AB - An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One hundred eighty-three participants were recruited, with a mean body mass index of 34.75 ± 2.75 kg/m2. General dropout rate at 6 months was 26.8%. Weight changes were statistically significant at months 3 and 6 compared to baseline, -2.915 ± 0.24 kg, -3.29 ± 0.36 kg, respectively (P < 0.001), but not statistically significant between the 3- and 6-month time points -0.37 ± 0.21 kg (P = 0.24). Mean group differences showed that the TI group lost 1.61 ± 1.88 kg more than the NTI group (P = 0.39). Waist, waist/hip ratio, resting heart rate, blood pressure, HbA1c, and low-density lipoprotein cholesterol also showed statistically significant changes at 6 months, with no significant differences between groups. Weight loss in the TI group shows similar results as the usual care NTI group for weight loss and control of obesity comorbidities. At completion of the clinical trial, these results will be reevaluated to assess the potential role of web support in weight-loss maintenance and its cost-effectiveness.

KW - Lifestyle modification.

KW - Metabolic syndrome

KW - Obesity

KW - Telemedicine

UR - http://www.scopus.com/inward/record.url?scp=85047529390&partnerID=8YFLogxK

U2 - 10.1089/dia.2017.0456

DO - 10.1089/dia.2017.0456

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Alcántara-Aragón V, Rodrigo-Cano S, Lupianez-Barbero A, Martinez MJ, Martinez C, Tapia J et al. Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. Diabetes Technology and Therapeutics. 2018 May;20(5):380-385. doi: 10.1089/dia.2017.0456

FAQs

How effective is semaglutide for weight loss? ›

The Semaglutide Treatment Effect in People With Obesity (STEP) trials have shown the efficacy of semaglutide for the treatment of obesity. In large RCTs, patients receiving semaglutide, 2.4 mg, lost a mean of 6% of their weight by week 12 and 12% of their weight by week 28.

Is Semaglutide used in obesity? ›

Semaglutide 2.4 mg is to be administered subcutaneously, once a week for adults with overweight (body mass index >27 kg/m2) with at least one weight-associated condition [for instance, high blood pressure, type 2 diabetes (T2DM), or high cholesterol], or adults with BMI of 30 kg/m2 or greater, received FDA approval in ...

Does semaglutide get rid of belly fat? ›

Semaglutide improves body composition by helping patients lose weight and reduce excess fat, including stubborn belly fat. It also increases the proportion of lean body mass. In general, the more weight you lose with semaglutide, the greater the improvements you'll see in your overall body composition across all areas.

What foods to avoid while taking semaglutide? ›

Fried foods and fatty foods, such as fast food, and foods high in sugar tend to be the toughest for your body to digest and the most likely to cause nausea while taking a GLP-1 medication.

Who Cannot use semaglutide? ›

Tell your doctor if you or anyone in your family has or has ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to take semaglutide.

Which is better semaglutide or phentermine? ›

Is semaglutide better than phentermine for weight loss? Semaglutide and phentermine are two different medications used to support weight loss. In higher doses, Wegovy (semaglutide) can support sustained weight loss with long-term use. Phentermine can also assist weight loss, but is only intended for short-term use.

Which is better Ozempic or semaglutide? ›

Ozempic for weight loss: which is better? In a clinical trial that compared weekly use of semaglutide 1 mg and 2.4 mg, semaglutide 2.4 mg (the maximum dose of Wegovy) caused more significant weight loss than semaglutide 1 mg (the typical maintenance dose of Ozempic) (Davies, 2021; Singh, 2022).

Where is the best place to inject semaglutide for weight loss? ›

Ozempic (semaglutide) is a once-weekly injection for people with Type 2 diabetes. It's injected under the skin (subcutaneously) of the stomach, thigh, or upper arm. It shouldn't make a difference which injection site you choose for injecting Ozempic. And you can stick with the same area or rotate areas each time.

How fast do you start losing weight on semaglutide? ›

While taking semaglutide, some people begin to see results within the first eight weeks, but most begin to see results within 12 weeks. Clinical trials have shown that study participants taking a weekly dose of semaglutide had an average reduction in body weight of 5-10 percent.

How much weight does the average person lose on semaglutide? ›

More than 85% of participants taking semaglutide lost 5% of their body weight, nearly 70% achieved a 10% weight loss, 50% achieved a 15% weight loss, and just under a third achieved a 20% weight loss.

Can semaglutide damage pancreas? ›

Although rare, pancreatitis has been reported with semaglutide. If it happens, it can be life-threatening. Seek immediate medical attention if you develop severe abdominal pain, nausea and vomiting, and/or jaundice (yellowing of skin and eyes).

What happens if a non diabetic takes semaglutide? ›

Semaglutide Promotes More Weight Loss in Nondiabetic Adults Than Liraglutide. Arlington, VA—Once-weekly SC semaglutide was significantly more effective than once-daily subcutaneous liraglutide in promoting weight loss in adults with overweight or obesity—but without diabetes, according to a new study.

What does Ozempic do to your face? ›

“Ozempic face” is a term for common side effects of the type 2 diabetes medication semaglutide (Ozempic). It can cause sagging and aging of facial skin. A doctor may recommend lifestyle modifications or facial fillers to treat these effects.

How quickly can you lose weight with semaglutide? ›

While taking semaglutide, some people begin to see results within the first eight weeks, but most begin to see results within 12 weeks. Clinical trials have shown that study participants taking a weekly dose of semaglutide had an average reduction in body weight of 5-10 percent.

How much weight can you lose in a month on semaglutide? ›

We did have patients who lost a moderate amount but we also had patients losing over 15 pounds and even over 20 pounds in the first month!

How long to take semaglutide for weight loss? ›

The FDA recommends that the dosage of semaglutide medication must be increased to its effective level of 2.4 mg during the 16 to 20 weeks of the therapy to include its weight loss benefits and other advantages and to reduce the impact of common side effects like gastrointestinal disorders.

How many units of semaglutide should I take to lose weight? ›

Usual Adult Dose for Weight Loss

Weeks 1 through 4: 0.25 mg subcutaneously once a week. Weeks 5 through 8: 0.5 mg subcutaneously once a week. Weeks 9 through 12: 1 mg subcutaneously once a week. Weeks 13 through 16: 1.7 mg subcutaneously once a week.

What is the best injection for weight loss? ›

4 Best injections for weight loss [2023 Review]
  • Saxenda.
  • Semaglutide.
  • Ozempic.
  • Wegovy.
Jan 20, 2023

Who should not take semaglutide? ›

Conditions: diabetic retinopathy, a type of damage to the eye from diabetes. low blood sugar. suicidal thoughts.

Will insurance cover semaglutide for weight loss? ›

Semaglutide is a safe and effective treatment for type 2 diabetes and chronic weight management. However, this weight loss drug is typically not covered by most insurance companies.

What happens after you stop semaglutide? ›

Semaglutide must be taken consistently to see long-term weight loss effects. As soon as someone stops taking the drug, their body fat and former appetite tend to return. Experts recommend working with a provider versed in obesity medicine to create a plan for improved lifestyle and long-term adherence to the drug.

Why do people regain weight after stopping semaglutide? ›

Dr. Louis Aronne , director of the Comprehensive Weight Control Center at Weill Cornell Medicine, told "GMA" that rebound weight gain can be common after stopping semaglutide because the drug is no longer working in the body.

How long does it take for Rybelsus to start working for weight loss? ›

by Drugs.com

The dose is increased from 3mg to 7mg after 30 days so you can expect Rybelsus to start showing an effect from day 31 onward. Every time you increase the dose of Rybelsus it takes 4 to 5 weeks for steady levels to be reached so it may take two to three months before the full effects of Rybelsus are seen.

How much does semaglutide cost per month? ›

Semaglutide Cost per Month

Wegovy brand of Semaglutide has a price tag of $1,500 for a month's supply. Because weight loss is not a label use, many insurance plans in the US do not cover the cost of Semaglutide for weight loss.

What are the side effects of semaglutide injections for weight loss? ›

What are the side effects of semaglutide injections?
  • Dizziness.
  • Fatigue.
  • Gastrointestinal issues, such as diarrhea, constipation and gassiness.
  • Headache.
  • Stomach issues, including nausea, vomiting, pain or distension (bloat)

Can you stay on semaglutide for life? ›

The hitch is that these drugs must be used throughout life, much like diabetes medications, or else the benefits are lost. In fact, a 2021 study led by Rubino found that people on semaglutide regain weight when the drug is stopped.

Does it matter what time of day you take semaglutide? ›

Semaglutide injection comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (under the skin). It is usually injected once a week without regard to meals. Use semaglutide injection on the same day each week at any time of day.

Does semaglutide slow your metabolism? ›

Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity. Diabetes Obes Metab.

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