RBR-7bxzh2r Smartphone application in the treatment of obesity in adolescents

Date of registration: 08/17/2021 ^(mm/dd/yyyy)
Last approval date : 08/17/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code:

• Public title:

  en

  Smartphone application in the treatment of obesity in adolescents

  pt-br

  Uso do aplicativo de smartphone no tratamento da obesidade em adolescentes.

• Scientific acronym:

  en

  SMARTO

  pt-br

  SMARTO

• Public acronym:

  en

  SMARTO

  pt-br

  SMARTO

• Secondaries identifiers:
  • U1111-1265-3646
    Issuing authority: Universal trial number
  • 88935218.2.0000.0068
    Issuing authority: Plataforma Brasil
  • 2.695.815
    Issuing authority: Comitê de Ética em Pesquisa (CEP) - FMUSP

Sponsors

• Primary sponsor: Hospital das Clínicas da Faculdade de Medicina de São Paulo
• Secondary sponsor:
  • Institution: Hospital das Clínicas da Faculdade de Medicina de São Paulo
• Supporting source:
  • Institution: Hospital das Clínicas da Faculdade de Medicina de São Paulo

Health conditions

• Health conditions:

  en

  Weight loss; Caloric Restriction

  pt-br

  Perda de peso; Restrição Calórica

• General descriptors for health conditions:

  en

  E66.0 IV - Endocrine, nutritional and metabolic diseases

  pt-br

  E66.0 IV - Doenças endocrinas, nutricionais e metabólicas

  en

  L01.224.230.260.550.500.500 Smartphone

  pt-br

  L01.224.230.260.550.500.500 Smartphone

• Specific descriptors:

  en

  C23.888.144.243.963 Weight loss

  pt-br

  C23.888.144.243.963 Perda de peso

  en

  E02.642.249.200 Caloric Restriction

  pt-br

  E02.642.249.200 Restrição Calórica

Interventions

• Interventions:

  en

  Conventional group: 30 participants with a balanced low-calorie diet, received guidance to carry out 3-day food recall on paper and application group: 30 participants with a balanced low-calorie diet associated with the use of smartphone app “Calorie Counter FatSecret”, to carry out daily food recall on it. Both groups were followed up with monthly consultations with an endocrinologist and nutritionist, for a period of 6 months.

  pt-br

  Grupo convencional: 30 participantes com dieta hipocalórica balanceada, recebeu orientação de realizar recordatório alimentar de 3 dias em papel e grupo aplicativo: 30 participantes com dieta hipocalórica balanceada associada ao uso do aplicativo de smartphone “Contador de Calorias FatSecret”, para realizar recordatório alimentar diariamente no mesmo. Ambos os grupos foram acompanhados com consultas mensais com endocrinologista e nutricionista., durante o período de 6 meses.

• Descriptors:

  en

  G07.203.650.240 Diet

  pt-br

  G07.203.650.240 Dieta

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 05/01/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	-	13 Y	17 Y

• Inclusion criteria:

  en

  Adolescents between 13 and 17 years old with a BMI z-score greater than or equal to 2

  pt-br

  Adolescentes entre 13 e 17 anos com escore Z do IMC maior ou igual a 2

• Exclusion criteria:

  en

  Illiterate individuals; without smartphone and internet access; not adhering to the project proposal; patients with decompensated endocrine diseases; genetic syndromes causing obesity; heart, kidney or liver failure; use of medications that cause weight gain or weight loss; cognitive deficit or psychiatric illness in activity or under treatment

  pt-br

  Indivíduos iletrados; sem acesso a smartphone e à internet; não aderentes à proposta do projeto; portadores de doenças endócrinas descompensadas; síndromes genéticas causadoras de obesidade; insuficiência cardíaca, renal ou hepática; em uso de medicações causadoras de aumento ou perda de peso; déficit cognitivo ou doença psiquiátrica em atividade ou em tratamento

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  After the intervetion, the intention to treat analysis showed a significantly greater reduction in ZIMC in the conventional group (p = 0.032). The Last Observation Carried Forward analysis showed a significant reduction in the ZIMC in both groups, with no difference between them (p = 0.543).

  pt-br

  Após a intervenção, na análise ITT (análise da intenção de tratar - Intention to treat), observou-se redução do ZIMC significativamente maior no grupo convencional (p = 0,032). Na análise LOCF (última observação efetuada - Last Observation Carried Forward), observou-se redução significativa do ZIMC em ambos os grupos, sem diferença entre eles (p = 0,543).

  en

  After the intervention, both Intention to treat and Last Observation Carried Forward analysis, showed a significant reduction in the percentage of body fat in both groups, with no difference between them (p = 0.27 and p = 0.68, respectively).

  pt-br

  Após a intervenção, tanto na análise Intention to treat quanto na Last Observation Carried Forward, observou-se redução significativa da porcentagem de gordura corporal em ambos os grupos, sem diferença entre eles (p = 0,27 e p = 0,68, respectivamente).

• Secondary outcomes:

  en

  At the end of the intervention, there was a reduction in waist circumference, waist / height ratio, an increase in the percentage of lean mass and a reduction in insulin, with no difference between groups. There was also a significant increase in HDL cholesterol and a significant reduction in HOMA-IR in the application group and a significant reduction in GPT in the conventional group.

  pt-br

  Ao final da intervenção observou-se redução da circunferência abdominal, da relação cintura/estatura, aumento do percentual de massa magra e redução da insulina, sem diferença entre os grupos. Observou-se ainda aumento significativo do HDL colesterol e redução significativa do HOMA-IR no grupo aplicativo e redução significativa de TGP no grupo convencional.

  en

  At the end of the intervention, no significant difference was observed in food consumption between the two groups. There was also a significant reduction in the consumption of carbohydrates and an increase in the consumption of poly and monounsaturated fats in the conventional group.

  pt-br

  Ao final da intervenção não foi observada diferença significativa no consumo alimentar entre os dois grupos. Observou-se ainda redução significativa do consumo de carboidratos e aumento do consumo de gorduras poli e monoinsaturadas no grupo convencional.

  en

  At the end of the intervention, no significant difference was observed in food consumption between the two groups. There was also a significant reduction in carbohydrates consumption and an increase in poly and monounsaturated fats consumption in the conventional group.

  pt-br

  Ao final da intervenção o grupo convencional apresentou melhora significativa no componente dor do questionário de qualidade de vida Short Form 36, em relação ao grupo aplicativo. Além disso, observou-se melhora significativa dos componentes capacidade funcional e dor no grupo convencional e melhora do significativa componente estado geral de saúde no grupo aplicativo.

  en

  At the end of the study, there was a significant reduction in the mean score of the Binge Eating Scale in both groups, in a similar way.

  pt-br

  Ao final do estudo houve redução significativa na média de escore da Escala de Compulsão Alimentar Periódica em ambos os grupos, de forma semelhante.

Contacts

• Public contact
  • Full name: Andrea Samara Audi
  • • Address: Rua, Av. Dr. Enéas Carvalho de Aguiar, 455
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +5511991708598
  • Email: andreaaudi1@gmail.com
  • Affiliation:
  • Full name: Marcio Correa Mancini
  • • Address: Rua, Av. Dr. Enéas Carvalho de Aguiar, 455, sala 11-A
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +55-11-26617516
  • Email: marcio.mancini@fm.usp.br
  • Affiliation:
   
• Scientific contact
  • Full name: Marcio Correa Mancini
  • • Address: Rua, Av. Dr. Enéas Carvalho de Aguiar, 455, sala 11-A
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +55-11-26617516
  • Email: marcio.mancini@fm.usp.br
  • Affiliation:
  • Full name: Andrea Samara Audi
  • • Address: Rua, Av. Dr. Enéas Carvalho de Aguiar, 455
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +5511991708598
  • Email: andreaaudi1@gmail.com
  • Affiliation:
   
• Site contact
  • Full name: Marcio Correa Mancini
  • • Address: Rua, Av. Dr. Enéas Carvalho de Aguiar, 455, sala 11-A
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +55-11-26617516
  • Email: marcio.mancini@fm.usp.br
  • Affiliation:
  • Full name: Andrea Samara Audi
  • • Address: Rua, Av. Dr. Enéas Carvalho de Aguiar, 455
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +5511991708598
  • Email: andreaaudi1@gmail.com
  • Affiliation:
   

Additional links:

• Download in ICTRP format